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

NCT ID: NCT06289335

Last Updated: 2024-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-05

Study Completion Date

2022-01-03

Brief Summary

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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

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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.

Conditions

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Postanesthetic Excitement Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Dexmedetomidine

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

Group Type ACTIVE_COMPARATOR

saline solution

Intervention Type DRUG

20 mL of saline

Ondansetron

8 mg ondansetron IV in 20 mL saline

Group Type SHAM_COMPARATOR

saline solution

Intervention Type DRUG

20 mL of saline

Interventions

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saline solution

20 mL of saline

Intervention Type DRUG

Other Intervention Names

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isotonic solution

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital Central "Dr. Ignacio Morones Prieto"

OTHER

Sponsor Role lead

Responsible Party

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MARIO AURELIO MARTÍNEZ-JIMÉNEZ

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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MARIO A MARTÍNEZ-JIMÉNEZ, Dr.

Role: STUDY_DIRECTOR

Hospital Central "Dr. Ignacio Morones Prieto"

Locations

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Hospital Central Dr. Ignacio Morones Prieto

San Luis Potosí City, , Mexico

Site Status

Countries

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Mexico

References

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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.

Reference Type BACKGROUND
PMID: 29756066 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29278601 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11682416 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9357885 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18205960 (View on PubMed)

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.

Reference Type RESULT
PMID: 26767820 (View on PubMed)

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.

Reference Type RESULT
PMID: 30643009 (View on PubMed)

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.

Reference Type RESULT
PMID: 27228512 (View on PubMed)

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.

Reference Type RESULT
PMID: 27138855 (View on PubMed)

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.

Reference Type RESULT
PMID: 28663651 (View on PubMed)

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.

Reference Type RESULT
PMID: 30501612 (View on PubMed)

Other Identifiers

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HCDrIMPrieto anaesthesia

Identifier Type: -

Identifier Source: org_study_id

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