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Completed

NCT Number: NCT02588547

Prevention of Spinal Induced Shivering During CS

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.

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Key information

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Seham Mohamed Moeen Ibrahim

Asyut, 71111, Egypt

About this study

The study will includes four groups as follows:

  • Granisetron1 group: women will receive 1mg IV granisetron
  • Granisetron 0.7 group: women will receive 0.7 mg IV granisetron and
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Granisetron

Drug

IV granisetron 1 mg before spinal anethesia

Other names: Kytril ampule 3mg/3ml IV (Roche)

Sodium Chloride

Drug

IV 2 ml 0.9 sodium chloride before spinal anethesia

Other names: 0.9 Sodium chloride

Primary outcomes

  1. shivering score

    Time frame: 180 min (immediately before the block till 180 min after the block)

Secondary outcomes

  1. non invasive blood pressure

    Time frame: 90 min (immediately before the block till 90 min after the block)

  2. heart rate

    Time frame: 90 min (immediately before the block till 90 min after the block)

  3. core temperature

    Time frame: 90 min (immediately before the block till 90 min after the block)

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 28, 2015
Registry last updated
Nov 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.