Nefopam Versus Ondansteron for Prevention of Post Spinal Shivering.

April 28, 2021 updated by: Saint-Joseph University

Comparative Study Between Nefopam and Ondansteron for Prevention of Post Spinal Shivering. A Randomized Controlled Trial.

Spinal anesthesia affects the homeostatic systems resulting in intraoperative hypothermia and subsequently shivering. In fact, shivering may be seen after this technique in 30 to 40% of cases . Ondansetron and Nefopam have been used to prevent intraoperative shivering . However, no prospective, randomized, double-blind study has been conducted to this date in order to compare nefopam with ondansetron in the prevention of post-spinal anesthesia shivering.

The primary objective of this prospective, randomized, double-blind study is to compare the incidence and intensity of shivering after spinal anesthesia for non-obstetric surgery in 2 groups of patients.

Group A: Patients receiving 8 mg of ondansetron diluted in 20 ml of 0.9% normal saline over 30 minutes as they arrive to the operating theater(75 patients).

• Group B: Patients receiving 20 mg of nefopam diluted in 20 ml of 0.9% normal saline over 30 minutes as they arrive to the operating theater (75 patients)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

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 Locations

  • Lebanon
      • Beirut, Lebanon
        • Recruiting
        • Universite Saint Joseph , Hotel Dieu de France
        • 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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age between 18 and 65 years
  • scheduled for a surgery under spinal anesthesia

Exclusion Criteria:

  • pregnant or breastfeeding (for the women), if they are
  • Allergy to any of the drugs to be used
  • Long QT syndrome
  • Hepatic insufficiency
  • Renal failure
  • Parkinson's disease
  • Epilepsy
  • Glaucoma
  • Phenylketonuria

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patients receiving Ondansetron
Drug: Ondansetron 8mg
Patients receiving 8 mg of ondansetron diluted in 20 ml of 0.9% normal saline over 30 minutes as they arrive to the operating theater(75 patients).
Active Comparator: Patients receiving Nefopam
Drug: Nefopam Injectable Solution
Patients receiving 20 mg of nefopam diluted in 20 ml of 0.9% normal saline over 30 minutes as they arrive to the operating theater (75 patients)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of shivering
Time Frame: Shivering score was noted every 15 minutes from drug administration up to 120 minutes.
Number of episodes of shivering and variation will be noted every 15 minutes from drug administration up to 120 minutes.
Shivering score was noted every 15 minutes from drug administration up to 120 minutes.
Grade of shivering
Time Frame: Shivering score was noted every 15 minutes from drug administration up to 120 minutes.
Grades of shivering will be noted every 15 minutes from drug administration up to 120 minutes. Shivering will be graded : 0 = no shivering, 1= piloerection or peripheral vasoconstriction but no visible shivering, 2 = muscular activity in only one muscle group, 3 = muscular activity in more than one muscle group but not generalized shivering, 4 = shivering involving the whole body.
Shivering score was noted every 15 minutes from drug administration up to 120 minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nausea/Vomitting
Time Frame: Every 15 minutes from drug administration up to 120 minutes
Number of episodes of nausea and/or vomiting during and after surgery.
Every 15 minutes from drug administration up to 120 minutes
Hypotention/Bradycardia
Time Frame: Every three minutes from drug administration up to 120 minutes.

Hypotention: Number of episodes of hypotension SBP <90mmhg or <25% of baseline SBP in post spinal anesthesia until discharge from the PACU.

Bradycardia: Number of episodes of bradycardia <50 / min post-spinal anesthesia until discharge from the PACU.
Every three minutes from drug administration up to 120 minutes.
Pain on injection site by analogue visual scale.
Time Frame: During administration of drug.
Pain upon administration of drug on site of injection will be assessed using the analogue visual scale .
During administration of drug.

Collaborators and Investigators

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

Sponsor

Saint-Joseph University

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)

December 1, 2020

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

March 30, 2021

First Submitted That Met QC Criteria

April 28, 2021

First Posted (Actual)

May 3, 2021

Study Record Updates

Last Update Posted (Actual)

May 3, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HDF15891

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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