OBJECTIVES: Cesarean delivery is commonly performed under regional anesthesia, which is often associated with maternal shivering. This can cause distress and interfere with monitoring. The study objective was to evaluate the antishivering efficacy of ondansetron, which reduces the incidence and severity of shivering in nonobstetric patients. We hypothesized that there would be a significant decrease in the incidence and/or severity of shivering in women who are given intravenous ondansetron 8 mg before combined spinal epidural (CSE) anesthesia, when compared with placebo. METHODS: This was a randomized, double-blinded, parallel-group, placebo-controlled trial of 118 women scheduled for elective cesarean surgery. Women received either intravenous ondansetron 8 mg (n = 58) or saline (n = 60) before CSE anesthesia (intrathecal hyperbaric bupivacaine 0.5% 2.2-2.5 mL plus fentanyl 15 μg). The incidence and severity of shivering, measured on a validated 5-point scale, and other outcomes, such as nausea, pruritus, headache, or satisfaction, were assessed at 3 time points during the surgery and postoperative period. RESULTS: The incidence of shivering at any time point did not differ significantly between groups: ondansetron 41% versus placebo 47% (P = 0.54). The incidence of severe shivering at any time was not significantly different: ondansetron 32% versus placebo 33% (P = 0.79). There were no significant differences between the groups for any secondary outcomes. CONCLUSIONS:Intravenous ondansetron 8 mg before performing CSE anesthesia in women undergoing elective cesarean delivery does not decrease the incidence or severity of shivering.
RCT Entities:
OBJECTIVES: Cesarean delivery is commonly performed under regional anesthesia, which is often associated with maternal shivering. This can cause distress and interfere with monitoring. The study objective was to evaluate the antishivering efficacy of ondansetron, which reduces the incidence and severity of shivering in nonobstetric patients. We hypothesized that there would be a significant decrease in the incidence and/or severity of shivering in women who are given intravenous ondansetron 8 mg before combined spinal epidural (CSE) anesthesia, when compared with placebo. METHODS: This was a randomized, double-blinded, parallel-group, placebo-controlled trial of 118 women scheduled for elective cesarean surgery. Women received either intravenous ondansetron 8 mg (n = 58) or saline (n = 60) before CSE anesthesia (intrathecal hyperbaric bupivacaine 0.5% 2.2-2.5 mL plus fentanyl 15 μg). The incidence and severity of shivering, measured on a validated 5-point scale, and other outcomes, such as nausea, pruritus, headache, or satisfaction, were assessed at 3 time points during the surgery and postoperative period. RESULTS: The incidence of shivering at any time point did not differ significantly between groups: ondansetron 41% versus placebo 47% (P = 0.54). The incidence of severe shivering at any time was not significantly different: ondansetron 32% versus placebo 33% (P = 0.79). There were no significant differences between the groups for any secondary outcomes. CONCLUSIONS: Intravenous ondansetron 8 mg before performing CSE anesthesia in women undergoing elective cesarean delivery does not decrease the incidence or severity of shivering.