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Dexmedetomidine after cesarean for the treatment of shivering: Blinded Interim Analysis
Abstract Number: T2H-244
Abstract Type: Original Research
BACKGROUND: Multiple factors including temperature changes, hormonal and psychological stress, and neuraxial anesthesia and contribute to peripartum shivering that is experienced by many women. Past studies have demonstrated a decreased incidence in postoperative shivering with IV dexmedetomidine (DEX) in non-obstetric surgeries.(1) Intrathecal DEX has been shown to reduce post-cesarean shivering,(2) but IV DEX has not been studied in the obstetric population. We hypothesized that patients undergoing scheduled cesarean who receive IV DEX might have reduced incidence and severity of post-operative shivering. The blinded interim safety analysis of our randomized study is presented here.
METHODS: We randomized patients to receive either normal saline or 10 mcg of IV DEX after birth during cesarean delivery. Spinal anesthesia included 11.25mg bupivacaine, 25mcg fentanyl, and 0.25mg morphine. Temperature was measured once before and within 1 hour of surgery. Demographic, obstetric and anesthetic data were collected. At baseline (pre-operatively) and 30- and 60-minutes after arrival in the recovery room, patients were asked to report their pain, nausea, pruritus, shivering, dry mouth, and sedation on a 0-10 continuous rating scale. At the same timepoints, investigators recorded objective signs of vomiting, and assessed shivering, pruritus and sedation using a 5-point Likert scale. We performed univariate assessment of the relationship between symptom severity and group assignment using the Mann-Whitney test, with p<0.025 considered significant.
RESULTS: 50 patients were enrolled and 38 completed the study; 19 in each group. Patient characteristics were similar between groups. Both the subjective and objective side effect scores measured at baseline, and also at 30 min and 60 min postoperatively were similar between groups (FIGURE). The percentages of patients who required postoperative medication for pain, nausea, pruritus and GI symptoms within 24 hours were also similar between groups.
CONCLUSIONS: DEX 10mcg administered IV after cesarean delivery does not cause significant side effects in patients undergoing scheduled cesarean delivery, including the need for additional medications in the post-operative period. It is safe to continue the study and complete our assessment of the effect of DEX on severity of postoperative shivering with a target sample size of 100.
1 Can J Anaesth 2015;62:816-29
2 Drug Des Devel Ther 2017;11:1107–1113