Intravenous Dexmeditomidine for Prevention of Spinal Anesthesia Induced Shivering.

May 5, 2022 updated by: Mohammad Shafiq, Rehman Medical Institute - RMI

Role of Dexmeditomidine HCL for Prevention of Shivering in Obstetrical Spinal Anesthesia, a Randomized Controlled Double Blind Parallel Study.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Intraoperative inadvertent changes in the body temperature are quite common. Incidence of inadvertent hypothermia (up to 90%) is much higher than hyperthermia. The hypothermic patients shiver postoperatively after general anesthesia and both introperatively and post operatively during regional anesthesia. Shivering under spinal anesthesia has an incidence of 40-60%. Shivering is not only uncomfortable for the patient; additionally it increases minute oxygen consumption VO2 at the cost of increased presser hormones level, subjecting the patient to a higher risk of cardiovascular complications. Heat loss from skin and surgical site is mostly by radiation. Dropped body temperature in cesarean section under spinal anesthesia is due to a combination of anesthetic-induced impaired thermoregulation i.e. vasodilation and inhibition of vasoconstriction in the blocked dermatomes, which are due to autonomic and motor blockade caused by spinal anesthesia. General anesthesia also leads to hypothermia due to vasodilation and reduced metabolic rate, in the order of 20%-30%. Additional factors are exposure to cold environment, un-warmed cold irrigants/ intra vascular fluids and ventilation with dry anesthetic gases. In spinal anesthesia, due to blocked motor activity below umbilicus, shivering in response to hypothermia is abolished. It interferes with physiologic heat recovery, as human core body temperature should normally be maintained within the narrow range of 36.5-37.5 °C. 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 which is an alpha-2 agonist, is a new drug used for analgesia and sedation either in perioperative settings or in intensive care units. It is 7-8 times selective alpha 2 agonist than clonidine and was expected to control shivering like clonidine. There are study demonstrating the favorable effect of Dexmeditomidine via infusion in the intraoperative period on shivering after abdominal hysterectomy. In previous studies, a prophylactic single dose of Dexmeditomidine for prevention or aborting shivering was generally found to be effective after general or regional anesthesia. Dexmedetomidine 0.5 mcg/kg I/v as loading dose was found 100% effective in managing post anesthesia shivering after general anesthesia in children. In another study, it was observed that Dexmedetomidine was equally effective compared to tramadol, and was associated with shorter time for complete shivering control and less incidence of nausea vomiting, but prospects of a single sub loading dose in parturients during spinal anesthesia requires exploration as physiologic volume loaded parturients at term are expected to lose more heat by redistribution due to vasodilation caused by spinal anesthesia.

OBJECTIVE: To determine the role of single sub loading dose of Dexmeditomidine i.e. 10 mcg (0.1- 0.2 microgram/kg) administered intravenously for prevention of shivering in participants undergoing Cesarean section under spinal anesthesia in a randomized double-blind, placebo controlled parallel study.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Khyber Pakhtunkhwa
      • Peshawar, Khyber Pakhtunkhwa, Pakistan, 25000
        • Recruiting
        • Rehman Medical Institute
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Rahman U Jan, MCPS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion criteria:

  • American Society of Anesthesiologists (ASA) physical status I and II ladies
  • Singleton pregnancies.
  • Undergoing elective Cesarean delivery under spinal anesthesia.
  • Systolic blood pressure ≥ 100 mm of Hg after umbilical cord clamping

Exclusion criteria:

  • ASA class III or above
  • Hyperthyroidism
  • Cardiopulmonary or respiratory disease
  • A psychological disorder
  • An initial body temperature of >37.5 °C or <36.5 °C
  • Systolic blood pressure <100 mm of Hg after umbilical cord clamping and/or mean arterial pressure (MAP) < 65 mm of Hg after umbilical cord clamping

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dexmedetomidine
This is group D, which will receive 10 micro-gram Dexmeditomidine diluted in 02 ml normal saline to be administered intravenously in 10 minutes after umbilical cord is clamped..
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..
Other Names:
  • inj Precidex (brookes pharmaceutical, Pakistan)
Active Comparator: Saline
This group S will receive 02 ml normal saline intravenously as placebo in 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.
Other Names:
  • Normal Saline 0.9 %

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of shivering in all parturients who received either Dexmeditomidine HCL or placebo
Time Frame: Two hours
The intensity of postoperative shivering will be graded using Bedside Shivering Assessment Scale(BSAS) from 0 - 3 with 0= no shivering and 3=severe shivering.
Two hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of sedation in all parturients who received either Dexmedetomidine HCL or placebo.
Time Frame: Two hours
Sedation will be assessed through Richmond agitation sedation scale (RASS) from +4 to - 5 with +4= combative and -5= unarousable.
Two hours
Rate of postoperative pain and analgesia in all parturients who received either Dexmeditomidine HCL or placebo.
Time Frame: Two hours
Postoperative pain/analgesia will be assessed through visual analogue scale (VAS) with 0= no pain, 100= very severe pain.
Two hours
Incidence of adverse reactions associated with Dexmedetomidine HCL
Time Frame: Two hours
Incidence of adverse reactions like hypotension and bradycardia in Dexmedetomidine group will be noted and compared with saline group
Two hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rehman Medical Institute - RMI

Investigators

  • Principal Investigator: Mohammad Shafiq, FCPS, Rehman Medical Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

April 16, 2022

First Submitted That Met QC Criteria

April 16, 2022

First Posted (Actual)

April 22, 2022

Study Record Updates

Last Update Posted (Actual)

May 11, 2022

Last Update Submitted That Met QC Criteria

May 5, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMI/RMI-REC/Approval/58

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Yes Data including clinical and demographic characteristics, not affecting patient's confidentiality, will be shared.

IPD Sharing Time Frame

April, 2022 to April, 2025

IPD Sharing Access Criteria

IPD will be shared on inter institutional request basis.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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