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Randomized controlled trial comparing ondansetron and placebo for the reduction of spinal anesthesia-induced hypotension during elective cesarean delivery in Egypt.
Int J Gynaecol Obstet 2016; 135(2):205-209IJ

Abstract

OBJECTIVE

To evaluate the effect of prophylactic ondansetron on spinal anesthesia-induced hypotension and bradycardia among patients undergoing elective cesarean deliveries.

METHODS

A prospective, double-blind, randomized, placebo-controlled trial enrolled patients aged 20-40years scheduled for elective cesarean delivery under spinal anesthesia between January 1, 2015 and January 31, 2016 at Menoufia University Hospital, Egypt. Patients were randomized to receive intravenous ondansetron 4mg in 10mL of saline or 10mL of saline. Participants and investigators were masked to group assignments. The primary outcomes were systolic and diastolic blood pressure, mean arterial pressure, and heart rate, measured at baseline, 10-minute intervals to 60minutes, and at 2hours. Per-protocol analyses were performed including patients who delivered under spinal anesthesia.

RESULTS

The analyses included 50 patients in each group. Decreases in systolic blood pressure were reduced among patients receiving ondansetron at all time points (P<0.05) and diastolic blood pressure did not differ between the groups (P>0.05). Among patients who received ondansetron, mean arterial pressure was higher immediately and 30minutes after spinal anesthesia (P<0.05), higher heart rates were recorded immediately, 20minutes, and 50minutes after anesthesia (P<0.05), and the incidence of nausea (P=0.020) and vomiting (P=0.031) were lower.

CONCLUSION

Prophylactic intravenous ondansetron significantly reduced hypotension and heart-rate fluctuations among patients undergoing elective cesarean deliveries under spinal anesthesia. Pan African Clinical Trials Registry: PACTR 201601001397193.

Authors+Show Affiliations

Department of Obstetrics and Gynecology, Faculty of Medicine, Menoufia University, Shibin Elkom, Egypt. Electronic address: nabih.elkhouly@yahoo.com.Department of Anesthesiology, Faculty of Medicine, Menoufia University, Shibin Elkom, Egypt.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

27578231

Citation

El Khouly, Nabih I., and Ashraf M. Meligy. "Randomized Controlled Trial Comparing Ondansetron and Placebo for the Reduction of Spinal Anesthesia-induced Hypotension During Elective Cesarean Delivery in Egypt." International Journal of Gynaecology and Obstetrics: the Official Organ of the International Federation of Gynaecology and Obstetrics, vol. 135, no. 2, 2016, pp. 205-209.
El Khouly NI, Meligy AM. Randomized controlled trial comparing ondansetron and placebo for the reduction of spinal anesthesia-induced hypotension during elective cesarean delivery in Egypt. Int J Gynaecol Obstet. 2016;135(2):205-209.
El Khouly, N. I., & Meligy, A. M. (2016). Randomized controlled trial comparing ondansetron and placebo for the reduction of spinal anesthesia-induced hypotension during elective cesarean delivery in Egypt. International Journal of Gynaecology and Obstetrics: the Official Organ of the International Federation of Gynaecology and Obstetrics, 135(2), pp. 205-209. doi:10.1016/j.ijgo.2016.06.012.
El Khouly NI, Meligy AM. Randomized Controlled Trial Comparing Ondansetron and Placebo for the Reduction of Spinal Anesthesia-induced Hypotension During Elective Cesarean Delivery in Egypt. Int J Gynaecol Obstet. 2016;135(2):205-209. PubMed PMID: 27578231.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized controlled trial comparing ondansetron and placebo for the reduction of spinal anesthesia-induced hypotension during elective cesarean delivery in Egypt. AU - El Khouly,Nabih I, AU - Meligy,Ashraf M, Y1 - 2016/08/12/ PY - 2016/01/17/received PY - 2016/05/29/revised PY - 2016/08/02/accepted PY - 2016/9/1/pubmed PY - 2017/5/17/medline PY - 2016/9/1/entrez KW - Cesarean delivery KW - Hypotension KW - Ondansetron KW - Spinal anesthesia SP - 205 EP - 209 JF - International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics JO - Int J Gynaecol Obstet VL - 135 IS - 2 N2 - OBJECTIVE: To evaluate the effect of prophylactic ondansetron on spinal anesthesia-induced hypotension and bradycardia among patients undergoing elective cesarean deliveries. METHODS: A prospective, double-blind, randomized, placebo-controlled trial enrolled patients aged 20-40years scheduled for elective cesarean delivery under spinal anesthesia between January 1, 2015 and January 31, 2016 at Menoufia University Hospital, Egypt. Patients were randomized to receive intravenous ondansetron 4mg in 10mL of saline or 10mL of saline. Participants and investigators were masked to group assignments. The primary outcomes were systolic and diastolic blood pressure, mean arterial pressure, and heart rate, measured at baseline, 10-minute intervals to 60minutes, and at 2hours. Per-protocol analyses were performed including patients who delivered under spinal anesthesia. RESULTS: The analyses included 50 patients in each group. Decreases in systolic blood pressure were reduced among patients receiving ondansetron at all time points (P<0.05) and diastolic blood pressure did not differ between the groups (P>0.05). Among patients who received ondansetron, mean arterial pressure was higher immediately and 30minutes after spinal anesthesia (P<0.05), higher heart rates were recorded immediately, 20minutes, and 50minutes after anesthesia (P<0.05), and the incidence of nausea (P=0.020) and vomiting (P=0.031) were lower. CONCLUSION: Prophylactic intravenous ondansetron significantly reduced hypotension and heart-rate fluctuations among patients undergoing elective cesarean deliveries under spinal anesthesia. Pan African Clinical Trials Registry: PACTR 201601001397193. SN - 1879-3479 UR - https://www.unboundmedicine.com/medline/citation/27578231/Randomized_controlled_trial_comparing_ondansetron_and_placebo_for_the_reduction_of_spinal_anesthesia_induced_hypotension_during_elective_cesarean_delivery_in_Egypt_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0020-7292(16)30299-5 DB - PRIME DP - Unbound Medicine ER -