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Prevention of Spinal Induced Shivering During CS

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT02588547
Collaborator
(none)
212
Enrollment
1
Location
3
Arms
18
Actual Duration (Months)
11.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
212 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Prophylactic Granisetron for the Prevention of Spinal Induced Shivering During Cesarean Section: a Prospective Double Blind Dose Ranging Clinical Study
Actual Study Start Date :
Nov 1, 2015
Actual Primary Completion Date :
May 1, 2017
Actual Study Completion Date :
May 1, 2017

Arms and Interventions

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)

    		•
    Active Comparator: Granisetron 0.7

    Intravenous granisetron 0.7 mg

    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. shivering score [180 min (immediately before the block till 180 min after the block)]

    Secondary Outcome Measures

    1. non invasive blood pressure [90 min (immediately before the block till 90 min after the block)]

    2. heart rate [90 min (immediately before the block till 90 min after the block)]

    3. core temperature [90 min (immediately before the block till 90 min after the block)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seham Mohamed Moeen Ibrahim Asyut Egypt 71111

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Principal Investigator: Seham M Moeen, MD, Assiut Univerisity

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seham Mohamed Moeen Ibrahim, lecturer, Assiut University
    ClinicalTrials.gov Identifier:
    NCT02588547
    Other Study ID Numbers:
    • SM102015
    First Posted:
    Oct 28, 2015
    Last Update Posted:
    Nov 17, 2017
    Last Verified:
    Nov 1, 2017
    Keywords provided by Seham Mohamed Moeen Ibrahim, lecturer, Assiut University
    Shivering
    Granisetron
    Spinal
    Cesarean section
    Additional relevant MeSH terms:
    Granisetron

    Study Results

    No Results Posted as of Nov 17, 2017