Clonidine Versus Granisetron for Shivering Prevension

Post Spinal Anesthesia Shivering Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06031090
• Other study ID #: zu-IRB#10415/26-2-2023
• Status: Recruiting
• Phase: Phase 2
• Start date: March 5, 2023
• Est. completion date: October 30, 2023

Study information

• Verified date: September 2023
• Source: Zagazig University
• Contact: Heba M Fathi, M.D
• Phone: 00201000143938
• Email: heba_elgendi[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 186
• Est. completion date: October 30, 2023
• Est. primary completion date: October 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 40 Years

Eligibility

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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Related Conditions & MeSH terms

• Post Spinal Anesthesia Shivering

Intervention

Drug:
• Clonidine Injection
intravenous Clonidine 0.5 µg/kg diluted in 10ml normal saline 20 minutes before spinal anesthesia
• Granisetron Injection
intravenous 1mg of granisetron diluted in 10ml normal saline 20 minutes before spinal anesthesia.
• Normal Saline 10 mL Injection
intravenous 10 ml normal saline 20 minutes before spinal anesthesia

Locations

Country	Name	City	State
Egypt	Heba M Fathi	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	maternal oxygen saturation		Procedure (preoperative as base and through out the period of spinal anesthesia)
Primary	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	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)
Secondary	Maternal Heart rate	beats/minute	Procedure (preoperative as base and through out the period of spinal anesthesia)
Secondary	baby APGAR score		1 minutes and 5 minutes post natal
Secondary	maternal blood presure	mmhg	Procedure (preoperative as base and through out the period of spinal anesthesia)