Clonidine Versus Granisetron for Shivering Prevension

Intravenous Clonidine Versus Granisetron for Prevention of Post Spinal Anesthesia Shivering in Cesarean Section

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

Study Overview

• Status: Recruiting
• Conditions: Post Spinal Anesthesia Shivering
• Intervention / Treatment: Drug: Clonidine Injection; Drug: Granisetron Injection; Drug: Normal Saline 10 mL Injection

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 Type: Interventional
• Enrollment (Estimated): 186
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Heba M Fathi, M.D; Phone Number: 00201000143938; Email: heba_elgendi@yahoo.com

Study Locations

• Egypt
  • Zagazig, Egypt, 44519
    • Recruiting
    • Heba M Fathi
    • Contact: Heba M Fathi, M.D; Phone Number: 002-01000143938; Email: heba_elgendi@yahoo.com

Participation Criteria

Eligibility Criteria

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

Description

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.

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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

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Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Shivering	• 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	Procedure (through out the period of spinal anesthesia)

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
maternal oxygen saturation	Procedure (preoperative as base and through out the period of spinal anesthesia)

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2023
• Primary Completion (Estimated): October 5, 2023
• Study Completion (Estimated): October 30, 2023

Study Registration Dates

• First Submitted: August 27, 2023
• First Submitted That Met QC Criteria: September 8, 2023
• First Posted (Actual): September 11, 2023

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 8, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Antiemetics; Gastrointestinal Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Serotonin Agents; Serotonin Antagonists; Serotonin 5-HT3 Receptor Antagonists; Sympatholytics; Granisetron; Clonidine
• Other Study ID Numbers: zu-IRB#10415/26-2-2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No