The efficacy and safety of ciprofol and propofol in patients undergoing colonoscopy: A double-blind, randomized, controlled trial.

STUDY OBJECTIVE: Propofol is a commonly utilized anesthetic for painless colonoscopy, but its usage is occasionally limited due to its potential side effects, including cardiopulmonary suppression and injection pain. To address this limitation, the novel compound ciprofol has been proposed as a possible alternative for propofol. This study sought to determine whether there are any differences in the safety and efficacy of propofol and ciprofol for painless colonoscopy. DESIGN: Randomized clinical trial. SETTING: Single-centre, class A tertiary hospital, November 2021 to November 2022. PATIENTS: Adult, American Society of Anesthesiologists Physical Status I to II and body mass index of 18 to 30 kg m-2 patients scheduled to undergo colonoscopy. INTERVENTIONS: Consecutive patients were randomly allocated in a 1:1 ratio to receive sedation for colonoscopy with ciprofol (group C) or propofol (group P). MEASUREMENTS: The primary outcome was the success rate of colonoscopy. The secondary outcomes were onset time of sedation, operation time, recovery time and discharge time, patients and endoscopists satisfaction, side effects (e.g. injection pain, myoclonus, drowsiness, dizziness, procedure recall, nausea and vomiting) and incidence rate of cardiopulmonary adverse events. MAIN RESULTS: No significant difference was found in the success rate of colonoscopy between the two groups (ciprofol 96.3% vs. propofol 97.6%; mean difference - 1.2%, 95% CI: -6.5% to 4.0%, P = 0.650). However, group C showed prolonged sedation (63.4 vs. 54.8 s, P < 0.001) and fully alert times (9 vs 8 min, P = 0.013), as well as reduced incidences of injection pain (0 vs. 40.2%, P < 0.001), respiratory depression (2.4% vs. 13.4%, P = 0.021) and hypotension (65.9% vs. 80.5%, P = 0.034). Patients satisfaction was also higher in Group C (10 vs 9, P < 0.001). CONCLUSIONS: Ciprofol can be used independently for colonoscopy. When comparing the sedation efficacy of ciprofol and propofol, a 0.4 mg kg-1 dose of ciprofol proved to be equal to a 2.0 mg kg-1 dose of propofol, with fewer side effects and greater patient satisfaction during the procedure.

Clinical observation of perioperative negative emotional changes in patients with percutaneous balloon compression for primary trigeminal neuralgia: A prospective cohort study.

OBJECTIVE: To investigate the prevalence of negative emotions in trigeminal neuralgia (TN) patients, to identify risk factors associated with anxiety and depression, and further to explore the impact of percutaneous balloon compression (PBC) on anxiety and depression in TN patients during the perioperative period. METHODS: 400 patients with primary TN treated with PBC at our institution from November 2021 to April 2023 were included. We analyzed visual analogue scale (VAS) and the Hospital Anxiety and Depression Scale (HADS) scores. The patients' clinical data and short-term clinical outcomes were gathered and subjected to statistical analysis. RESULTS: This study included a total of 400 patients diagnosed with primary TN. Patients who had high pain intensity (OR 1.20, 95 % CI 1.02-1.41; p = 0.025) or a history of multiple previous TN procedures (OR 1.49, 95 % CI 1.03-2.16; p = 0.036), were more prone to anxiety. Patients who were female (OR 1.59, 95 % CI 1.03-2.44; p = 0.036), had high pain intensity (OR 1.28, 95 % CI 1.08-1.52; p = 0.004) or had a history of multiple previous TN procedures (OR 1.48, 95 % CI 1.11-1.98; p = 0.008), were more likely to have depression. Significant improvements in anxiety and depressive symptoms were observed in patients who experienced pain relief after PBC (p < 0.001). CONCLUSIONS: Female gender, high pain intensity, and a history of multiple prior TN procedures are associated risk factors for anxiety and depression in TN patients. PBC can provide patients with a high pain relief rate and significantly improve their anxiety and depression symptoms during the perioperative period.

The effect of music intervention on sedation in elderly patients undergoing transurethral resection of prostate under spinal anesthesia: a prospective randomized controlled clinical trial.

PURPOSE: Music intervention is commonly used as a non-pharmacologic therapeutic modality to alleviate anxiety in perioperative patients. This study aimed to assess the sedative and anxiolytic effects of music on elderly patients receiving transurethral resection of prostate (TURP) under spinal anesthesia. METHODS: This was a prospective randomized controlled trial on patients who aged over 60 and received TURP under spinal anesthesia. Participants were randomized to the music group or the control group (no music). The primary outcome was perioperative BIS values, and the secondary outcomes were patient's perioperative anxiety levels, heart rate (HR), blood pressure, and patient satisfaction score. RESULTS: A total of 82 patients were analyzed. The perioperative BIS values in the music group were significantly lower than those of the control group at almost all time points (P < 0.001), as well as showed a significant reduction compared with baseline (P < 0.001), whereas the control group did not. In comparison with the control group, systolic blood pressure (SBP) significantly decreased in the music group at the beginning (mean difference, - 8.0 mmHg; 95% CI - 15.70 to 0.35; P = 0.041) and the 60th minute (mean difference, - 7.9 mmHg; 95% CI - 15.30 to 0.51; P = 0.037) of TURP. Furthermore, compared with baseline within the music group, diastolic blood pressure (DBP) and HR significant reduced at whole time points (P < 0.05), yet the control group not. CONCLUSION: Music intervention effectively provided slight sedation for elderly patients when undergoing TURP under spinal anesthesia without sedatives.

A comparative study on the efficacy and safety of propofol combined with different doses of alfentanil in gastroscopy: a randomized controlled trial.

PURPOSE: Propofol can be used alone or in combination with opioids during gastroscopy. This study aimed to assess the efficacy and safety of intravenous propofol and different doses of alfentanil in patients undergoing gastroscopy. METHODS: A total of 300 patients undergoing sedative gastroscopy were randomly divided into four groups, and 0.9% saline (group A), 2 µg/kg alfentanil (group B), 3 µg/kg alfentanil (group C) or 4 µg/kg alfentanil (group D) were injected intravenously 1 min before the intravenous injection of 1.5 mg/kg propofol. If body movement and coughing occurred during the procedure, 0.5 mg/kg propofol would be administered intravenously. The primary outcome (awakening time) and secondary outcomes were recorded and analyzed, including hemodynamic changes, the incidences of body movement, coughing, hypoxemia, hypotension, hypertension, bradycardia, tachycardia, nausea and vomiting, drowsiness and dizziness. RESULTS: Patients in group C (7.0 [5.0 to 8.0] min) and group D (6.0 [5.0 to 7.0] min) woke up significantly earlier than those in group A (8.0 [6.0 to 10.0] min) (P < 0.001). Patients in group A experienced more body movement (P = 0.001) and coughing (P < 0.001) than the other groups. With the increasing dose of alfentanil, the morbidity of hypotension and bradycardia increased significantly (P = 0.001), while the incidence of dizziness decreased significantly (P = 0.037). The incidences of hypoxemia, tachycardia, drowsiness, nausea and vomiting were similar among the four groups (P > 0.05). CONCLUSIONS: Intravenous 1.5 mg/kg propofol combined with 3 µg/kg alfentanil is more suitable for patients undergoing gastroscopy, and the dose of alfentanil can be reduced according to the patient's actual physical condition.

The Effect of Atropine on Trigeminocardiac Reflex-induced Hemodynamic Changes During Therapeutic Compression of the Trigeminal Ganglion.

BACKGROUND: Percutaneous compression of the trigeminal ganglion (PCTG) can induce significant hemodynamic perturbations secondary to the trigeminocardiac reflex (TCR). The aim of this study was to investigate the effect of atropine pretreatment on hemodynamic responses during PCTG for trigeminal neuralgia. MATERIALS AND METHODS: A total of 120 patients who received PCTG were randomly assigned to control and atropine groups that were pretreated with saline (n=60) and atropine 0.004 mg/kg intravenously (n=60), respectively. Heart rate (HR) and mean arterial pressure (MAP) were measured at 9 timepoints from before induction of anesthesia until the end of the PCTG procedure; the incidence of TCR was also observed. RESULTS: HR was higher in the atropine compared with control group from the time of skin puncture with the PCTG needle until after the procedure was completed (P<0.05). MAP was also higher in the atropine compared with control group, but only at entry of the needle into the foramen ovale until 1 minute after trigeminal ganglion compression (P<0.05). HR was reduced in both groups during entry of the needle into the foramen ovale and during ganglion compression, but less so in the atropine compared with the control group (P<0.05). MAP increased during PCTG compared with baseline in both groups, but with a larger increase in the atropine group (P<0.05). Two and 52 cases in the control group, and 6 and 1 cases in the atropine group, exhibited a TCR during entry of the needle into the foramen ovale and at ganglion compression, respectively (P<0.05). CONCLUSION: Pretreatment with atropine was effective in most patients at minimizing abrupt reduction in HR during PCTG.

The Effect of Depth of Anesthesia on Hemodynamic Changes Induced by Therapeutic Compression of the Trigeminal Ganglion.

BACKGROUND: Percutaneous compression of the trigeminal ganglion (PCTG) has been used to treat trigeminal neuralgia since 1983. A PCTG-related trigeminocardiac reflex (TCR) can induce dramatic hemodynamic disturbances. This study investigates the effects of depth of propofol anesthesia on hemodynamic changes during PCTG. MATERIALS AND METHODS: A total of 120 patients who underwent PTCG for trigeminal neuralgia were randomly assigned to control group-intravenous saline pretreatment before PCTG puncture and anesthesia targeted to bispectral index (BIS) 40 to 60 throughout, and study group-intravenous propofol 1 to 2 mg/kg pretreatment to deepen anesthesia to BIS<40 before PCTG. Mean arterial pressure, heart rate (HR), cardiac output, system vascular resistance, and BIS were measured at 9 time points during the procedure, and the incidence of the TCR was observed at T5 and T6. RESULTS: BIS was lower in the study group compared with the control after pretreatment with propofol or saline, respectively. Compared with the control group, mean arterial pressure was lower in the study group at several points during the procedure, but there was no difference in HR between the 2 groups at any point. Cardiac output was higher and system vascular resistance lower in the study compared with the control group. In the control group, 42 (70.0%) and 52 (86.7%) of patients developed a TCR at the 2 points, and 37 (67.1%) and 45 (75.0%) in the study group. There was no difference in the incidence of TCR between the 2 groups. CONCLUSION: Increasing the depth of propofol anesthesia partially attenuated PTCG-related elevation of blood pressure but did not modify the abrupt reduction in HR.

Comparative Study of Atropine Combined with Sodium Nitroprusside Pretreatment to Prevent Trigemino Cardiac Reflex after Trigeminal Ganglion Compression.

INTRODUCTION: Manipulation of percutaneous compression of the trigeminal ganglion (PCTG) for trigeminal neuralgia (TN) can lead to significant haemodynamic changes, which were termed trigemino cardiac reflex (TCR). Nevertheless, many studies indicated that atropine pretreatment can reduce the incidence of bradycardia and cardiac arrest, but do not take precautions against abrupt rise of blood pressure. AIM: The purpose of our study was to compare control group {patients receiving Sodium Nitro-Prusside (SNP) pretreatment before PCTG} with study groups (patients receiving different doses of atropine combined with SNP pretreatment before PCTG) in cardiovascular parameters {Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Heart Rate (HR)} at 5 periods during Total Intravenous Anaesthesia (TIVA). MATERIALS AND METHODS: In total, 120 patients, who underwent PTCG, were enrolled and randomly assigned into control group {group A (SNP pretreatment before PCTG, n=29)} and study groups {group B (0.002mg /kg atropine combined with SNP pretreatment before PCTG, n=30), C (0.004mg/kg atropine pretreatment before PCTG, n=31) and D (0.006mg/kg atropine combined with SNP pretreatment before PCTG, n=30)}, the relationship between haemodynamic changes and using atropine pretreatment or not was compared. Cardiovascular parameters were measured at five periods: preoperative (T0); before puncture (T1); during compression (T2); 1 min after the compression ended (T3); and 1 min after the procedure ended (T4). Multivariate analysis of variance (MANOVA) and Pearson's χ(2) test were used, and a value of p < 0.05 was considered statistically significant. RESULTS: Compared with the group A, means of SBP and DBP in the study groups (group B, C and D) were not observed significant differences at all time points (p>0.05), the mean values of HR showed significant differences, when compared to group C and group D at T2 and T3 (p<0.001). Meanwhile, means of SBP, DBP and HR comparison in the same group were observed between T1 and T2, to the group A, B and D, means of HR (p>0.05 vs. T1) indicated significant differences, however, there was no significant difference in group C (p>0.05). Furthermore, the incidence of post-compression tachycardia was observed in each group. CONCLUSION: By comparison, it seemed that 0.004mg/kg atropine pretreatment before PCTG was more reasonable for preventing significant haemodynamic changes.

Comparative study of trigeminocardiac reflex after trigeminal ganglion compression during total intravenous anesthesia.

BACKGROUND: Percutaneous compression of the trigeminal ganglion (PCTG) is an alternative surgical treatment for trigeminal neuralgia (TN). Manipulation of PCTG can lead to significant hemodynamic changes, which may increase the risk of cardiovascular complications. However, to our knowledge, few studies have focused on anesthesia experience during PCTG as treatment for TN so far. It was our primary focus on how to ensure the stability of hemodynamics during our clinical anesthesia experience. This study aimed to compare the study group (using sodium nitroprusside [SNP] as soon as the puncture began) with the control group (without using SNP as soon as the puncture began) to investigate cardiovascular parameters (systolic blood pressure [SBP], diastolic blood pressure [DBP], and heart rate [HR]) at 5 periods during total intravenous anesthesia. METHODS: A total of 256 patients who underwent PTCG were enrolled and randomly assigned into the study group (n=137) (using SNP as soon as the puncture began) and the control group (n=119) (without using SNP as soon as puncture began); the relationship between the hemodynamic changes and using SNP or without using SNP was compared. Blood pressure and HR were measured at 5 periods: preoperative (T1), before puncture (T2), during compression (T3), 1 minute after compression ended (T4), and 1 minute after the procedure ended (T5). Multivariate analysis of variance and the Pearson χ test were used, and a value of P<0.05 was considered statistically significant. RESULTS: The mean values of SBP were higher in the control group at the evaluation during T3 (P<0.001 vs. control), T4 (P<0.05 and P=0.040 vs. control), and T5 (P<0.05 and P=0.037 vs. control) and DBP was the only observed significant difference during T3 (P<0.001 vs. control), when compared with the study group. Meanwhile, means of SBP, DBP, and HR comparison in the same group were observed between T2 and T3. In the control group, means of SBP (P<0.001 vs. T2), DBP (P<0.001 vs. T2), and HR (P<0.001 vs. T2) showed significant differences in comparison with control group; means of HR (P<0.001 vs. T2) was the only observed significant difference between T2 and T3 in the study group. However, PTCG elicited significant abrupt bradycardia during T3 in almost all patients. CONCLUSIONS: The control group and the study group were not able to prevent bradycardia elicited during PTCG. Compared with control group, dramatic elevations of the systemic blood pressure can be prevented using intravenous drip SNP as soon as the puncture began during total intravenous anesthesia in the study group. Our findings verify that intravenous drip SNP is an effective method to control abrupt rise of blood pressure.