Prevention of Shivering Associated With Spinal Anesthesia

October 8, 2023 updated by: Ahmed Galal Mohammed Mohammed, Assiut University

Dexmedetomidine Versus Ketamine to Prevent Shivering Associated With Intrathecal Anesthesia in Patients Undergoing Knee Arthroscopy:A Randomized, Controlled Double Blinded Study.

The aim of the study is to compare the effectiveness of prophylactic use of intravenous (IV) dexmedetomidine VS ketamine and meperidine(as a control group) in prevention of shivering associated with intrathecal anesthesia in patients undergoing knee arthroscopy

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 2
  • Phase 3

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

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

- BMI 20-30 Scheduled patients for knee arthroscopy under spinal anesthesia. American Society of Anesthesiologists (ASA) physical status: I and II

Exclusion Criteria:

  • Patient refusal Aged less than 18 years or lesser than 150 cm in height Pregnant woman Allergy to the studied drugs. Patients with contraindications to spinal anesthesia. Patients with advanced decompensated cardiac, respiratory,renal or hepatic diseases, ASA III-IV Coagulopathy or thrombocytopenia CNS diseases as epilepsy, stroke or psychiatric illness.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group D (dexmedetomidine group)
Drug: Dexmedetomidine
Patients will receive dexmedetomidine 0.5 mcg/kg diluted in 10 mL of NS given as IV infusion over 10 min before induction of spinal anesthesia
Active Comparator: Group K (ketamine group)
Drug: Ketamine
Patient will will receive ketamine 0.5 mg/kg diluted in 10 mL of NS given as IV infusion over 10 min before induction of spinal anesthesia
Placebo Comparator: Group C (control group)
Drug: Meperidine
If the tested drug hasn't stopped shivering patient will receive 0.25 mg/kg meperidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of shivering
Time Frame: During operation time
Incidence of shivering post intrathecal anesthesia is recorded
During operation time

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Director: Essam Ez Abdelhakeem, Professor, Assiut University
  • Study Director: Seham Mo Moeen, Professor, Assiut University

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 (Estimated)

November 1, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

October 8, 2023

First Submitted That Met QC Criteria

October 8, 2023

First Posted (Actual)

October 13, 2023

Study Record Updates

Last Update Posted (Actual)

October 13, 2023

Last Update Submitted That Met QC Criteria

October 8, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Shivering and anesthesia

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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