Dexmedetomidine Compared to Ondansetron for Postanaesthetic Shivering in Patients Undergoing a Cesarean Section

Phase 2

Completed

• Conditions: Cesarean Section; Postanesthetic Excitement
• Interventions: Drug: saline solution

• Registration Number: NCT06289335
• Lead Sponsor: Hospital Central "Dr. Ignacio Morones Prieto"

Brief Summary

Evaluate the efficiency of management with intravenous dexmedetomidine compared to intravenous ondansetron to achieve the disappearance of post-anesthetic shivering in a shorter time in the obstetric patient undergoing cesarean section under regional anesthesia.

Detailed Description

Randomized clinical trial with 40 pregnant patients, between 18 and 45 years old with ASA (American Society of Anesthesiologist) II or III, undergoing scheduled or emergency cesarean section with regional anesthesia and who presented grade tremor 1 based on the BSAS (Bedside shivering assessment scale) scale, at the Hospital Central from San Luis Potosi, Mexico. The main objective of this study was to quantify the time that elapsed from the end of the administration of the medication until the disappearance of the tremor, which was measured in minutes; The evaluation of the disappearance, persistence or reappearance of the tremor was solely visual by the anesthesiology staff.

Study Timeline

• Study Start: 2020-08-05
• Primary Completion: 2021-09-05
• Study Completion: 2022-01-03
• Status Verified: 2024-02
• Study First Submitted: 2024-02-26
• Study First Submitted QC: 2024-02-26
• Last Update Submitted: 2024-02-26
• Study First Posted: 2024-03-01
• Last Update Posted: 2024-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• ASA II or III, undergoing scheduled or emergency cesarean section with regional anesthesia (hyperbaric bupivacaine 0.5% with morphine at 1 mcg Kg-1) and who presented tremor grade >1 based on the BSAS scale

Exclusion Criteria

• Hemodynamic instability, heart disease or sinus bradycardia, allergy to any of the medications applied, psychiatric diseases or hypothermia <35.2 ºC measured by tympanic temperature.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine	saline solution	0.3 mcg Kg-1 (actual weight) of dexmedetomidine IV in 20 mL of saline
Ondansetron	saline solution	8 mg ondansetron IV in 20 mL saline

Primary Outcome Measures

Name	Time	Method
Period of time	one hour	period of time in which post-anesthetic tremor is controlled from the moment of administration

Secondary Outcome Measures

Name	Time	Method
Adverse effects	one hour	To measure the frequencies of occurrence of adverse effects and changes in vital signs (heart rate, blood pressure, and temperature \[measured at the tympanic membrane\]) correlated with resolution of tremor.

Trial Locations

Locations (1)

Hospital Central Dr. Ignacio Morones Prieto; 🇲🇽 San Luis Potosí, Mexico