Clinical trial NCT06289335: Dexmedetomidine Compared to Ondansetron for Postanaesthetic Shivering in Patients Undergoing a Cesarean Section
Official title: Dexmedetomidine Compared With Ondansetron in Treating Postanesthetic Shivering in Patients After Regional Anesthesia for Cesarean Section-a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postanesthetic Excitement
Cesarean Section
Keywords: shivering, dexmedetomidine, ondansetron, regional anesthesia
Lead sponsor: Hospital Central "Dr. Ignacio Morones Prieto"
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Period of time
timeFrame: one hour
Secondary outcomes:
measure: Adverse effects
timeFrame: one hour
Other outcomes:
Locations:
city: San Luis Potosí
country: Mexico
facility: Hospital Central Dr. Ignacio Morones Prieto
Study officials:
affiliation: Hospital Central "Dr. Ignacio Morones Prieto"
name: MARIO A MARTÍNEZ-JIMÉNEZ, Dr.
role: STUDY_DIRECTOR
References:
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citation: Abdel-Ghaffar HS, Mohamed SA, Fares KM, Osman MA. Safety and Efficacy of Dexmedetomidine in Treating Post Spinal Anesthesia Shivering: A Randomized Clinically Controlled Dose-Finding Trial. Pain Physician. 2016 May;19(4):243-53.
citation: He K, Zhao H, Zhou HC. Efficiency and safety of ondansetron in preventing postanaesthesia shivering. Ann R Coll Surg Engl. 2016 Jul;98(6):358-66. doi: 10.1308/rcsann.2016.0152. Epub 2016 May 3.
citation: Nallam SR, Cherukuru K, Sateesh G. Efficacy of Intravenous Ondansetron for Prevention of Postspinal Shivering during Lower Segment Cesarean Section: A Double-Blinded Randomized Trial. Anesth Essays Res. 2017 Apr-Jun;11(2):508-513. doi: 10.4103/aer.AER_26_17.
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