Intravenous Granisetron Vs Dexmedetomidine on Postspinal in the Cesarean Section.

Not Applicable

• Conditions: Postspinal Shivering
• Interventions: Drug: Dexmedetomidine; Drug: Granisetron; Other: Placebo

• Registration Number: NCT06762860
• Lead Sponsor: Minia University

Brief Summary

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.

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 Timeline

• Status Verified: 2024-01
• Study Start: 2024-01-01
• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2025-01-05
• Last Update Submitted: 2025-01-07
• Study First Posted: 2025-01-08
• Last Update Posted: 2025-01-09
• Primary Completion: 2025-01-30
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 99

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine Group	Dexmedetomidine	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.
Granisetron Group	Granisetron	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.
Control Group	Placebo	Patients in this group will receive 10 ml normal saline 0.9% over 10 minutes immediately after clamping of the cord (placebo control group).

Primary Outcome Measures

Name	Time	Method
The incidence and severity of post spinal shivering.	every 10 minutes intraoperatively and every 15 minutes postoperatively for 4 hours	-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.

Secondary Outcome Measures

Name	Time	Method
change in the basal axillary temperature.	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	Changes in basal axillary temperature (Celsius (°C) scale) of the patient after administration of tested drugs.
change in the basal mean arterial blood pressure	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.	Changes in the basal non-invasive mean arterial blood pressure( millimetres mercury (mmHg)) of the patient after administration of tested drugs.
Change in the basal heart rate	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 heart rate of the patient after administration of tested drugs (beat per minute)

Trial Locations

Locations (1)

Minya University Faculty of Medicine; 🇪🇬 Minya, Egypt