Clonidine Versus Granisetron for Shivering Prevension

• Sponsor: Zagazig University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06031090
• Collaborator: (none)
• Enrollment: 186
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 7.9
• Patients Per Site Per Month: 23.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Post Spinal Anesthesia Shivering	Drug: Clonidine Injection; Drug: Granisetron Injection; Drug: Normal Saline 10 mL Injection	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 186 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Masking Description: triple blinded
• Primary Purpose: Prevention
• Official Title: Intravenous Clonidine Versus Granisetron for Prevention of Post Spinal Anesthesia Shivering in Cesarean Section
• Actual Study Start Date: Mar 5, 2023
• Anticipated Primary Completion Date: Oct 5, 2023
• Anticipated Study Completion Date: Oct 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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).

2. Maternal Heart rate [Procedure (preoperative as base and through out the period of spinal anesthesia)]

   beats/minute

3. baby APGAR score [1 minutes and 5 minutes post natal]

4. maternal blood presure [Procedure (preoperative as base and through out the period of spinal anesthesia)]

   mmhg

Other Outcome Measures

1. maternal oxygen saturation [Procedure (preoperative as base and through out the period of spinal anesthesia)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

-

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Heba M Fathi	Zagazig		Egypt	44519

Sponsors and Collaborators

• Zagazig University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Heba M Fathi, Ass. Professor, Zagazig University
• ClinicalTrials.gov Identifier: NCT06031090
• Other Study ID Numbers: zu-IRB#10415/26-2-2023
• First Posted: Sep 11, 2023
• Last Update Posted: Sep 11, 2023
• Last Verified: Sep 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Clonidine; Granisetron

Study Results

No Results Posted as of Sep 11, 2023