Comparison of Intravenous Ondansetron and Low Dose Ketamine in Preventing Post Spinal Shivering

Mayo Hospital Lahore

Status: Completed

Conditions: Postoperative Shivering; Postspinal Shivering

Treatments: Drug: Ketamine (0.25 mg/kg); Drug: ondansetron

Study type: Interventional

Funder types: Other

Identifiers

NCT07334223

Mayo1

Details and patient eligibility

About

This randomized controlled trial assessed whether intravenous ondansetron is more effective than low dose ketamine in preventing shivering after spinal anesthesia in adults undergoing elective surgery. Post spinal shivering is a frequent and uncomfortable complication of spinal anesthesia and may increase oxygen demand and interfere with routine monitoring. Adults aged 20 to 70 years (body weight 50 to 80 kg; American Society of Anesthesiologists class I to II) scheduled for elective procedures under standardized spinal anesthesia were randomly allocated in equal numbers to receive either ondansetron 8 mg intravenously or ketamine 0.25 mg/kg intravenously, administered 5 minutes after the spinal injection. Perioperative temperature management was standardized for all participants. The primary outcome was the occurrence of post spinal shivering during intraoperative monitoring. Among 180 participants, shivering occurred in 30.0% of those receiving ondansetron and 44.4% of those receiving ketamine, showing a statistically significant reduction with ondansetron.

Enrollment: 180 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients of either gender aged 20-60 years with ideal body
• weight of 50 to 80 kg.
• Patients meeting ASA classification I and II determined by
• anesthesiologist.
• Patients undergoing elective surgeries under spinal anesthesia.
• Duration of surgery should not be more than 3 hours.

Exclusion criteria

• Patients having a documented history of severe adverse reactions to ketamine or ondansetron.
• Patients with cardiovascular disease documented in history.
• Patients with hepatic disease documented in history and supported by lab results (AST 32-40U/L), ALT(10-40U/L).
• Patients with renal disease documented in history and supported by lab results. Urea (10-50mg/dl) S/Creatinine (0.3-1.5mg/dl).
• Patients with hyperthyroidism documented in history and supported by lab results.
• Patients with history of mental illness, seizures and glaucoma.
• Patients with known hypertension (BP greater than 140/90).
• Haemodynamically unstable patients (BP<100mmHg).
• Patients with coagulopathy or other bleeding diathesis documented in history and supported by lab results.
• Complicated prolonged surgeries in spinal anesthesia.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

Group Ondansetron

Experimental group

Description:

Received 8 mg of ondansetron administered intravenously five minutes after spinal anesthesia for prophylaxis of post spinal shivering.

Treatment:

Drug: ondansetron

Group Low Dose Ketamine

Active Comparator group

Description:

Received ketamine 0.25 mg per kilogram administered intravenously five minutes after spinal anesthesia for prophylaxis of post spinal shivering.

Treatment:

Drug: Ketamine (0.25 mg/kg)