Clonidine Versus Granisetron for Shivering Prevension

Phase 2

Recruiting

• Conditions: Post Spinal Anesthesia Shivering
• Interventions: Drug: Clonidine Injection; Drug: Granisetron Injection; Drug: Normal Saline 10 mL Injection

• Registration Number: NCT06031090
• Lead Sponsor: Zagazig University

Brief Summary

Prevention of post spinal anesthesia shivering during cesarean section with its associated discomfort, distress, aggravation of pain, increased metabolic demands, and increased oxygen consumption

Detailed Description

Shivering is one of the most important periperative complications seen in clinical practice. Several mechanisms have been postulated for its pathogenesis. Anesthetic-induced inhibition of thermoregulation resulting in hypothermia is an important cause of post anesthesia shivering, uncontrolled spinal reflexes, and cutaneous vasodilation are the other suggested mechanisms involved in the pathogenesis of shivering. Opioid receptors, α2 receptors, and serotonergic receptors also are involved of shivering.

Various drugs were studied for their potential role in prevention of peri-operative shivering such as tramadol, dexmedetomidine, ondansetron, ketamine, and pethidine.

We decided to perform a well-designed study to compare clonidine and granisetron which has been recently introduced as drugs for prevention and control of shivering after spinal anesthesia.

Study Timeline

• Study Start: 2023-03-05
• Study First Submitted: 2023-08-27
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-08
• Last Update Submitted: 2023-09-08
• Study First Posted: 2023-09-11
• Last Update Posted: 2023-09-11
• Primary Completion: 2023-10-05
• Study Completion: 2023-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 186

Inclusion Criteria

Patient acceptance.,Aged between 21-40 years old, BMI: 18- 30 kg/m2, ASA: I and II., Scheduled for elective cesarean section under spinal anesthesia.

Exclusion Criteria

History of hypersensitivity to drugs used in this study,Patients with history of chronic pain and taking analgesics, Patients with sepsis and Significant cardiac, liver or renal diseases, Uncooperative patients or with psychiatric disorders that prevent surgery under spinal anesthesia, Atrio-ventricular block in any degree, cardiac arrhythmias, valvular heart disease, kidney or liver diseases, neuromuscular disorders and diabetes mellitus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Cl (clonidine group)	Clonidine Injection	will be given intravenous Clonidine 0.5 µg/kg diluted in 10ml normal saline 20 minutes before spinal anesthesia
Group G (granisetron group)	Granisetron Injection	will be given intravenous 1mg of granisetron 20 minutes before spinal anesthesia.
Group C (control group)	Normal Saline 10 mL Injection	will be given intravenous10ml normal saline 20 minutes before spinal anesthesia

Primary Outcome Measures

Name	Time	Method
Incidence of Shivering	Procedure (through out the period of spinal anesthesia)	• Shivering will be graded according to Tsai and Chu scale (10): 0 = no shivering, 1 = piloerection or peripheral vasoconstriction but no visible shivering, 2 = muscular activity in only one muscle group, 3 = muscular activity in more than one muscle group but not generalized shivering, 4 =shivering involving the whole body

Secondary Outcome Measures

Name	Time	Method
core body temperature	Procedure (preoperative as base and through out the period of spinal anesthesia)	Core body temperature was detected by measuring tympanic membrane temperature using digital infrared ear thermometer (thermoscan KFT-10; Grnzia, genova, Italy).
Maternal Heart rate	Procedure (preoperative as base and through out the period of spinal anesthesia)	beats/minute
baby APGAR score	1 minutes and 5 minutes post natal
maternal blood presure	Procedure (preoperative as base and through out the period of spinal anesthesia)	mmhg

Trial Locations

Locations (1)

Heba M Fathi; 🇪🇬 Zagazig, Egypt