Clinical trial NCT02588547: Prevention of Spinal Induced Shivering During CS
Official title: Prophylactic Granisetron for the Prevention of Spinal Induced Shivering During Cesarean Section: a Prospective Double Blind Dose Ranging Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Spinal Induced Shivering
Keywords: Shivering
Granisetron
Spinal
Cesarean section
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2015-10-28
Enrollment: 212
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: shivering score
timeFrame: 180 min (immediately before the block till 180 min after the block)
Secondary outcomes:
measure: non invasive blood pressure
timeFrame: 90 min (immediately before the block till 90 min after the block)
measure: heart rate
timeFrame: 90 min (immediately before the block till 90 min after the block)
measure: core temperature
timeFrame: 90 min (immediately before the block till 90 min after the block)
Other outcomes:
Locations:
city: Asyut
country: Egypt
facility: Seham Mohamed Moeen Ibrahim
Study officials:
affiliation: Assiut Univerisity
name: Seham M Moeen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abdel-Ghaffar HS, Moeen SM. Prophylactic granisetron for post-spinal anesthesia shivering in cesarean section: A randomized controlled clinical study. Acta Anaesthesiol Scand. 2019 Mar;63(3):381-388. doi: 10.1111/aas.13084. Epub 2018 Feb 8.