Intravenous Granisetron Vs Dexmedetomidine on Postspinal in the Cesarean Section.

The Effect of Intravenous Granisetron Versus Intravenous Dexmedetomidine on Shivering Following Spinal Anesthesia in the Cesarean Section. a Randomized Controlled Comparative Trial .

The Aim of this study is to investigate and compare the efficacy of intravenous Dexmedetomidine (0.3 ug/kg) versus intravenous Granisetron (3 mg) in the prevention of shivering in parturient undergoing cesarean section under spinal anesthesia.

Study Overview

• Status: Enrolling by invitation
• Conditions: Postspinal Shivering
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Granisetron; Other: Placebo

Detailed Description

Study groups:

Randomization will be done according to computer guided table with sealed closed envelopes prepared by the supervisor, All study drugs will be prepared by the supervisor. Each group will be 25 patients.

• Study Type: Interventional
• Enrollment (Estimated): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Minya, Egypt
    • Minya University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• patients scheduled for cesarean section under spinal anesthesia.
• age : (20-45) years old.
• American Society of Anesthesia (ASA) physical status I, II.

Exclusion Criteria:

• Patient refusal.
• Contraindication to spinal anesthesia.
• BMI > 35 kg/m².
• Impaired renal, hepatic and cardiac function.
• Thyroid disease.
• Body temperature >38 °C or < 36.5 °C.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexmedetomidine Group; Patients in this group will receive (0.3 ug/kg) intravenous dexmedetomidine added to normal saline to get 10 ml of colorless solution and injected over 10 minutes after clamping of the cord.	Drug: Dexmedetomidine; label sticker
Active Comparator: Granisetron Group; Patients in this group will receive 3mg intravenous Granisetron added to normal saline to get 10 ml of colorless solution and injected over 10 minutes immediately after clamping of the cord.	Drug: Granisetron; label sticker
Placebo Comparator: Control Group; Patients in this group will receive 10 ml normal saline 0.9% over 10 minutes immediately after clamping of the cord (placebo control group).	Other: Placebo; label sticker

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence and severity of post spinal shivering.	-The Shivering will be graded on a scale Tsai and Chu [Tsai et al .,2001] : Grade 0= No shivering. Grade 1=Piloerection or peripheral vasoconstriction but no visible shivering. Grade 2=Muscular activity in only one muscle group. Grade 3=Muscular activity in more than one muscle group but not generalized. Grade 4=Shivering involving the whole body.	every 10 minutes intraoperatively and every 15 minutes postoperatively for 4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in the basal axillary temperature.	Changes in basal axillary temperature (Celsius (°C) scale) of the patient after administration of tested drugs.	preoperatively, immediately after spinal block and at 5 ,15 ,30 ,45 minutes and at the end of surgery, then every 15 minutes for 4 hour postoperatively
change in the basal mean arterial blood pressure	Changes in the basal non-invasive mean arterial blood pressure( millimetres mercury (mmHg)) of the patient after administration of tested drugs.	preoperatively, immediately after spinal block and at 5 ,15 ,30 ,45 minutes and at the end of surgery, then every 15 minutes for 4 hour postoperatively.
Change in the basal heart rate	Change in the heart rate of the patient after administration of tested drugs (beat per minute)	preoperatively, immediately after spinal block and at 5 ,15 ,30 ,45 minutes and at the end of surgery, then every 15 minutes for 4 hour postoperatively.

Collaborators and Investigators

• Sponsor: Minia University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): January 30, 2025
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: January 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 7, 2025
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: shivering after spinal anesthesia in cesarean section
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Hypnotics and Sedatives; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Serotonin 5-HT3 Receptor Antagonists; Serotonin Antagonists; Serotonin Agents; Dexmedetomidine; Granisetron
• Other Study ID Numbers: postspinal shivering

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No