Prevention of Spinal Induced Shivering During CS

November 13, 2017 updated by: Seham Mohamed Moeen Ibrahim, Assiut University

Prophylactic Granisetron for the Prevention of Spinal Induced Shivering During Cesarean Section: a Prospective Double Blind Dose Ranging Clinical Study

This study compares the efficacy of two different doses of intravenous (IV) granisetron on the prevention of postspinal shivering during cesarean section, in comparison with placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will includes four groups as follows:

  1. Granisetron1 group: women will receive 1mg IV granisetron
  2. Granisetron 0.7 group: women will receive 0.7 mg IV granisetron and
  3. Control group: women will receive 2 ml of 0.9% sodium chloride. Throughout the study period,shivering scores, core temperature, sensory level and motor block will be recorded, heart rate will be measured continuously using an electrocardiogram; blood pressure will be determined. If heart rate decreases by more than 20% of the baseline atropin will be received and if blood pressure decreases 20% of the baseline ephedrine will be received.

Also, Apgar score at one minute and five minutes will be recorded. At the end patient satisfaction will be assessed using Verbal Numeric Scoring system Side effects (bradycardia, hypotension, hypothermia, nausea and vomiting, pruritus etc ) will be recorded perioperatively in the operating room and postanesthetic care unit.

Study Type

Interventional

Enrollment (Actual)

212

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • Egypt
      • Asyut, Egypt, 71111
        • Seham Mohamed Moeen Ibrahim

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

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • pregnant women at term,
  • ASA status I or II (American Society of Anesthesiologists) physical status class I-II,
  • low-risk cesarean section,
  • Scheduled for the spinal anesthesia

Exclusion Criteria:

  • Pregnant women in labor
  • Patients who have the body temperature over 37.3 or less than 37 celsius degree
  • Known allergies to the study drugs
  • Contraindication to spinal anesthesia

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: Granisetron 1
Intravenous granisetron 1 mg
Drug: Granisetron
IV granisetron 1 mg before spinal anethesia
Other Names:
  • Kytril ampule 3mg/3ml IV (Roche)
Drug: Granisetron
IV granisetron 0.7 mg before spinal anethesia
Other Names:
  • Kytril ampule 3mg/3ml IV (Roche)
Active Comparator: Granisetron 0.7
Intravenous granisetron 0.7 mg
Drug: Granisetron
IV granisetron 1 mg before spinal anethesia
Other Names:
  • Kytril ampule 3mg/3ml IV (Roche)
Drug: Granisetron
IV granisetron 0.7 mg before spinal anethesia
Other Names:
  • Kytril ampule 3mg/3ml IV (Roche)
Placebo Comparator: Placebo
intravenous 0.9% Sodium chloride (2 ml)
Drug: Sodium chloride
IV 2 ml 0.9 sodium chloride before spinal anethesia
Other Names:
  • 0.9 Sodium chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
shivering score
Time Frame: 180 min (immediately before the block till 180 min after the block)
180 min (immediately before the block till 180 min after the block)

Secondary Outcome Measures

Outcome Measure
Time Frame
non invasive blood pressure
Time Frame: 90 min (immediately before the block till 90 min after the block)
90 min (immediately before the block till 90 min after the block)
heart rate
Time Frame: 90 min (immediately before the block till 90 min after the block)
90 min (immediately before the block till 90 min after the block)
core temperature
Time Frame: 90 min (immediately before the block till 90 min after the block)
90 min (immediately before the block till 90 min after the block)

Collaborators and Investigators

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

Sponsor

Assiut 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)

November 1, 2015

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

October 24, 2015

First Submitted That Met QC Criteria

October 27, 2015

First Posted (Estimate)

October 28, 2015

Study Record Updates

Last Update Posted (Actual)

November 17, 2017

Last Update Submitted That Met QC Criteria

November 13, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SM102015

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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