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

NCT06289335 | Completed Phase 2

• 1 other identifier: HCDrIMPrieto anaesthesia
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Postanesthetic Excitement; Cesarean Section

Keywords

shivering, dexmedetomidine, ondansetron, regional anesthesia

Outcome Measures

Primary Outcomes (1)

• Period of time

  period of time in which post-anesthetic tremor is controlled from the moment of administration

  one hour

Secondary Outcomes (1)

• Adverse effects

  one hour

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

0.3 mcg Kg-1 (actual weight) of dexmedetomidine IV in 20 mL of saline

Drug: saline solution

Ondansetron

SHAM COMPARATOR

8 mg ondansetron IV in 20 mL saline

Drug: saline solution

Interventions

saline solution DRUG

20 mL of saline

Also known as: isotonic solution

Dexmedetomidine; Ondansetron

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Central "Dr. Ignacio Morones Prieto": lead

Study Sites (1)

Hospital Central Dr. Ignacio Morones Prieto

San Luis Potosí City, 78290, Mexico

Location

Related Publications (11)

• Lopez MB. Postanaesthetic shivering - from pathophysiology to prevention. Rom J Anaesth Intensive Care. 2018 Apr;25(1):73-81. doi: 10.21454/rjaic.7518.251.xum.

  PMID: 29756066 BACKGROUND

• Jain A, Gray M, Slisz S, Haymore J, Badjatia N, Kulstad E. Shivering Treatments for Targeted Temperature Management: A Review. J Neurosci Nurs. 2018 Apr;50(2):63-67. doi: 10.1097/JNN.0000000000000340.

  PMID: 29278601 BACKGROUND

• Tsai YC, Chu KS. A comparison of tramadol, amitriptyline, and meperidine for postepidural anesthetic shivering in parturients. Anesth Analg. 2001 Nov;93(5):1288-92. doi: 10.1097/00000539-200111000-00052.

  PMID: 11682416 BACKGROUND

• Talke P, Tayefeh F, Sessler DI, Jeffrey R, Noursalehi M, Richardson C. Dexmedetomidine does not alter the sweating threshold, but comparably and linearly decreases the vasoconstriction and shivering thresholds. Anesthesiology. 1997 Oct;87(4):835-41. doi: 10.1097/00000542-199710000-00017.

  PMID: 9357885 BACKGROUND

• Elvan EG, Oc B, Uzun S, Karabulut E, Coskun F, Aypar U. Dexmedetomidine and postoperative shivering in patients undergoing elective abdominal hysterectomy. Eur J Anaesthesiol. 2008 May;25(5):357-64. doi: 10.1017/S0265021507003110. Epub 2008 Jan 21.

  PMID: 18205960 BACKGROUND

• Hoffman J, Hamner C. Effectiveness of dexmedetomidine use in general anesthesia to prevent postoperative shivering: a systematic review. JBI Database System Rev Implement Rep. 2016 Jan 15;13(12):287-313. doi: 10.11124/jbisrir-2015-2257.

  PMID: 26767820 RESULT

• Yu G, Jin S, Chen J, Yao W, Song X. The effects of novel alpha2-adrenoreceptor agonist dexmedetomidine on shivering in patients underwent caesarean section. Biosci Rep. 2019 Feb 1;39(2):BSR20181847. doi: 10.1042/BSR20181847. Print 2019 Feb 28.

  PMID: 30643009 RESULT

• 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.

  PMID: 27228512 RESULT

• 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.

  PMID: 27138855 RESULT

• 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.

  PMID: 28663651 RESULT

• Botros JM, Mahmoud AMS, Ragab SG, Ahmed MAA, Roushdy HMS, Yassin HM, Bolus ML, Goda AS. Comparative study between Dexmedetomidine and Ondansteron for prevention of post spinal shivering. A randomized controlled trial. BMC Anesthesiol. 2018 Nov 30;18(1):179. doi: 10.1186/s12871-018-0640-3.

  PMID: 30501612 RESULT

MeSH Terms

Conditions

Emergence Delirium

Interventions

Saline Solution; Isotonic Solutions

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• MARIO A MARTÍNEZ-JIMÉNEZ, Dr.

  Hospital Central "Dr. Ignacio Morones Prieto"

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 1, 2024
• Study Start: August 5, 2020
• Primary Completion: September 5, 2021
• Study Completion: January 3, 2022
• Last Updated: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)