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Intravenous Dexmeditomidine for Prevention of Spinal Anesthesia Induced Shivering.

NCT05342376 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-05-11

No results posted yet for this study

Summary

Intraoperative and post operative shivering is a common problem encountered in operating rooms and recovery suites. Shivering under spinal anesthesia has an incidence of 40-60%. Shivering is not only uncomfortable for the patient; additionally it increases minute oxygen consumption, subjecting the patient to a higher risk of cardiovascular complications. A variety of drugs like pethidine, fentanyl, alfentanil, sufentanil, buprenorphine, doxapram, clonidine, and ketanserin, are reported to be effective in suppressing postoperative shivering, yet an ideal drug/ method to be explored. Dexmeditomidine, a sedative and analgesic, may control shivering without significant adverse effects, like nausea and vomitting and respiratory depression.

The study design will be randomized controlled parallel trials with sample size of 80,They will be randomized into two equal groups. One group will receive 10 microgram Inj. Dexmeditomedine while the other will recieve inj. normal saline as placebo. The participants will be assessed for intra- and postoperative shivering.

Conditions

  • Postoperative Shivering
  • Cesarean Delivery

Interventions

DRUG

Dexmedetomidine Hydrochloride

The parturients will receive 10 micro-gram Dexmedetomidine diluted in 02 ml normal saline to be administered intravenously over 10 minutes after umbilical cord is clamped..

DRUG

Normal Saline

The parturients will receive 02 ml normal saline as placebo, to be administered intravenously over 10 minutes after umbilical cord is clamped.

Sponsors & Collaborators

  • Rehman Medical Institute - RMI

    lead OTHER

Principal Investigators

  • Mohammad Shafiq, FCPS · Rehman Medical Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2022-06-30
Completion
2022-12-31

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05342376 on ClinicalTrials.gov