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

Cesarean Section Clinical Trial

Official title:

Dexmedetomidine Compared With Ondansetron in Treating Postanesthetic Shivering in Patients After Regional Anesthesia for Cesarean Section-a Randomized Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06289335
• Other study ID #: HCDrIMPrieto anaesthesia
• Status: Completed
• Phase: Phase 2
• Start date: August 5, 2020
• Est. completion date: January 3, 2022

Study information

• Verified date: February 2024
• Source: Hospital Central "Dr. Ignacio Morones Prieto"
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 3, 2022
• Est. primary completion date: September 5, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section
• Emergence Delirium

Intervention

Drug:
• saline solution
20 mL of saline

Locations

Country	Name	City	State
Mexico	Hospital Central Dr. Ignacio Morones Prieto	San Luis Potosí

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Central "Dr. Ignacio Morones Prieto"

Country where clinical trial is conducted

Mexico, 

References & Publications (11)

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. — View Citation

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):17 — View Citation

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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View 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_ — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Period of time	period of time in which post-anesthetic tremor is controlled from the moment of administration	one hour
Secondary	Adverse effects	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.	one hour