Hemodynamic and antiemetic effects of prophylactic hyoscine butyl-bromide during cesarean section under spinal anesthesia: a randomized controlled trial.

BACKGROUND: Abrupt bradycardia and hemodynamic instability during spinal anesthesia for cesarean section are not uncommon and are considered as one of the primary causes of intraoperative nausea and vomiting (IONV). We hypothesized that prophylactic use of hyoscine butyl-bromide (HBB) could improve hemodynamics and reduce IONV in parturients undergoing cesarean section. METHODS: A randomized, double-blind placebo-controlled trial was carried out in a tertiary university hospital, patients scheduled for elective cesarean section were equally randomized to receive either IV HBB 20 mg in 1 ml (Hyoscine group) or the same volume of 0.9% saline (Control group), one minute after spinal anesthesia. The primary endpoint was the incidence of intraoperative bradycardia (HR < 50 beats min-1). Secondary endpoints included changes in mean arterial blood pressure (MAP), the incidence of Intraoperative and Postoperative nausea or vomiting (IONV & PONV), the fetal heart rate and, Apgar score. RESULTS: Of the 160 subjects randomized, 80 received HBB and 80 received placebo. There was a significant reduction in the incidence of the primary endpoint of intraoperative bradycardia (HR < 50 beats min-1) in the Hyoscine group (0% vs 10%; OR = 0.05, 95% CI = [0.003, 0.93]; P = 0.004) compared with placebo. MAP showed an insignificant difference between groups over time. HBB significantly decreased incidences of IONV and PONV (p = 0.002 & 0.004) respectively. CONCLUSIONS: In parturients undergoing cesarean section under spinal anesthesia, pretreatment with intravenous HBB was a safe measure for both the mother and the baby to reduce the risk of severe intraoperative bradycardia, but not hypotension. Furthermore, it was associated with less incidence of both IONV and PONV. TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT04069078.

Effects of terlipressin infusion during hepatobiliary surgery on systemic and splanchnic haemodynamics, renal function and blood loss: a double-blind, randomized clinical trial.

BACKGROUND: Terlipressin, in general, is a vasopressor which acts via V1 receptors. Its infusion elevates mean blood pressure and can reduce bleeding which has a splanchnic origin. The primary outcome was to assess the impact of intraoperative terlipressin infusion on portal venous pressure during hepatobiliary surgery; the 2ry outcomes included effects upon systemic hemodynamics, estimated blood loss, and postoperative renal functions. METHODS: This prospective randomized study involved 50 patients undergoing hepatobiliary surgery who were randomly and equally allocated into terlipressin group, or a control group. The terlipressin group received an initial bolus dose of (1 mg over 30 min) followed by a continuous infusion of 2 µg/kg/h throughout the procedure and gradually weaned over the first four postoperative hours, whereas the control group received the same volumes of normal saline. The portal venous pressure changes were measured directly through a portal vein angiocatheter. RESULTS: Portal pressure was significantly reduced over time in the terlipressin group only (from 17.88 ± 7.32 to 15.96 ± 6.55 mmHg, p < .001). Mean arterial blood pressure was significantly higher in the terlipressin group. Estimated blood loss was significantly higher in the control group than the terlipressin group (1065.7 ± 202 versus 842 ± 145.5 ml; p = 0.004), and the units of packed RBCs transfused were significantly higher in the control group ((0-2) versus (0-4) p = 0.003). There was no significant difference between groups as regards the incidence of acute kidney injury. CONCLUSION: Intraoperative infusion of terlipressin during hepatobiliary surgery was shown to improve intraoperative portal hemodynamics with subsequent reduction in blood loss. TRIAL REGISTRATION: Clinical trial number and registry URL: Trial registration number: NCT02718599 . Name of registry: ClinicalTrials.gov. URL of registry: https://clinicaltrials.gov/ct2/show/NCT02718599 . Date of registration: March 2016. Date of enrolment of the first participant to the trial: April 2016.