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

H

Hospital Central "Dr. Ignacio Morones Prieto"

Status and phase

Completed
Phase 2

Conditions

Cesarean Section
Postanesthetic Excitement

Treatments

Drug: saline solution

Study type

Interventional

Funder types

Other

Identifiers

NCT06289335
HCDrIMPrieto anaesthesia

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

Dexmedetomidine
Active Comparator group
Description:
0.3 mcg Kg-1 (actual weight) of dexmedetomidine IV in 20 mL of saline
Treatment:
Drug: saline solution
Ondansetron
Sham Comparator group
Description:
8 mg ondansetron IV in 20 mL saline
Treatment:
Drug: saline solution

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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