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OpenTrials
Completed

NCT Number: NCT07334223

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

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.

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Key information

Conditions

Postoperative Shivering Postspinal Shivering

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ondansetron

Drug

8 mg ondansetron administered intravenously as a single dose five minutes after spinal anesthesia.

Other names: Serotonin type 3 receptor antagonist

Ketamine (0.25 mg/kg)

Drug

0.25 mg per kilogram ketamine administered intravenously as a single dose five minutes after spinal anesthesia.

Other names: N-methyl-D-aspartate receptor antagonist

Primary outcomes

  1. Frequency of Post Spinal Shivering

    Time frame: From 5 minutes after administration of study drug until transfer of the patient to the post-anesthesia care unit

    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.

Sponsors and collaborators

Lead sponsor

Mayo Hospital Lahore

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 12, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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