An interventional study of ondansetron and Ketamine (0.25 mg/kg) in Postoperative Shivering and Postspinal Shivering, sponsored by Mayo Hospital Lahore. Completed at 1 site in Pakistan. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Mayo Hospital Lahore · Not applicable, Interventional, and Treatment
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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.
Mayo Hospital Lahore is the lead sponsor of 16 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
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The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Received 8 mg of ondansetron administered intravenously five minutes after spinal anesthesia for prophylaxis of post spinal shivering.
Drug: ondansetron
Received ketamine 0.25 mg per kilogram administered intravenously five minutes after spinal anesthesia for prophylaxis of post spinal shivering.
Drug: Ketamine (0.25 mg/kg)
8 mg ondansetron administered intravenously as a single dose five minutes after spinal anesthesia.
Also known as: Serotonin type 3 receptor antagonist
Drug page: Ketamine
0.25 mg per kilogram ketamine administered intravenously as a single dose five minutes after spinal anesthesia.
Also known as: N-methyl-D-aspartate receptor antagonist
Frequency of Post Spinal Shivering
Occurrence of post spinal shivering following administration of study medication, assessed clinically by the anesthesiology team and recorded as present or absent during intraoperative monitoring after spinal anesthesia.
Time frame: From 5 minutes after administration of study drug until transfer of the patient to the post-anesthesia care unit
Ran from Jul 2020 to primary completion in Jan 2021, 6 months.
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Studies of the drug tested here: Ondansetron
Mayo Hospital Lahore