Clonidine Versus Granisetron for Shivering Prevension

Zagazig University

Status and phase: Enrolling; Phase 2

Conditions: Post Spinal Anesthesia Shivering

Treatments: Drug: Clonidine Injection; Drug: Granisetron Injection; Drug: Normal Saline 10 mL Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06031090

zu-IRB#10415/26-2-2023

Details and patient eligibility

About

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

Full 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.

Enrollment: 186 estimated patients

Sex: Female

Ages: 21 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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186 participants in 3 patient groups, including a placebo group

Group Cl (clonidine group)

Active Comparator group

Description:

will be given intravenous Clonidine 0.5 µg/kg diluted in 10ml normal saline 20 minutes before spinal anesthesia

Treatment:

Drug: Clonidine Injection

Group G (granisetron group)

Active Comparator group

Description:

will be given intravenous 1mg of granisetron 20 minutes before spinal anesthesia.

Treatment:

Drug: Granisetron Injection

Group C (control group)

Placebo Comparator group

Description:

will be given intravenous10ml normal saline 20 minutes before spinal anesthesia

Treatment:

Drug: Normal Saline 10 mL Injection