Prevention of Spinal Induced Shivering During CS

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02588547

Enrollment

212

Registered

2015-10-28

Start date

2015-11-30

Completion date

2017-05-31

Last updated

2017-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Induced Shivering

Keywords

Shivering, Granisetron, Spinal, Cesarean section

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.

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.

Interventions

DRUGGranisetron

IV granisetron 1 mg before spinal anethesia

DRUGSodium chloride

IV 2 ml 0.9 sodium chloride before spinal anethesia

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
shivering score	180 min (immediately before the block till 180 min after the block)

Secondary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026