Postoperative ShiveringNCT07334223
Comparison of Intravenous Ondansetron and Low Dose Ketamine in Preventing Post Spinal Shivering
A study testing ondansetron and Ketamine (0.25 mg/kg) in people with Postoperative Shivering and Postspinal Shivering, run by Mayo Hospital Lahore at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Postoperative Shivering, Postspinal Shivering
- What is being tested?
- ondansetron and Ketamine (0.25 mg/kg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2020to 30 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Postoperative Shivering, Postspinal Shivering
- Being tested
- ondansetron, Ketamine (0.25 mg/kg)
- Keywords
- Spinal anesthesia, Postoperative shivering, Shivering prophylaxis, Ondansetron, Ketamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ondansetronDrug
Also called Serotonin type 3 receptor antagonist
8 mg ondansetron administered intravenously as a single dose five minutes after spinal anesthesia.
Ketamine (0.25 mg/kg)Drug
Also called N-methyl-D-aspartate receptor antagonist
0.25 mg per kilogram ketamine administered intravenously as a single dose five minutes after spinal anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Group Ondansetron | Experimental | Received 8 mg of ondansetron administered intravenously five minutes after spinal anesthesia for prophylaxis of post spinal shivering. Receives: Drug: ondansetron |
| Group Low Dose Ketamine | Active comparator | Received ketamine 0.25 mg per kilogram administered intravenously five minutes after spinal anesthesia for prophylaxis of post spinal shivering. Receives: Drug: Ketamine (0.25 mg/kg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From 5 minutes after administration of study drug until transfer of the patient to the post-anesthesia care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start1 Jul 2020
- Primary completion30 Jan 2021
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ShiveringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Hospital Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adeel Ahmed, Mayo Hospital Lahore
- Investigators
- Adeel Ahmed, Principal investigator, Mayo Hospital Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334223
- Sponsor's protocol ID
- Mayo1
- Status last verified
- Jan 2026
- First submitted
- 3 Jan 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intravenous Ondansetron and Low Dose Ketamine in Preventing Post Spinal Shivering
- ClinicalTrials.gov ID
- NCT07334223
- Acronym / sponsor ID
- Mayo1
- Conditions
- Postoperative Shivering, Postspinal Shivering
- Keywords
- Spinal anesthesia, Postoperative shivering, Shivering prophylaxis, Ondansetron, Ketamine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Mayo Hospital LahoreUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Ondansetron | Experimental | Drug: ondansetronReceived 8 mg of ondansetron administered intravenously five minutes after spinal anesthesia for prophylaxis of post spinal shivering. |
| Group Low Dose Ketamine | Active comparator | Drug: Ketamine (0.25 mg/kg)Received ketamine 0.25 mg per kilogram administered intravenously five minutes after spinal anesthesia for prophylaxis of post spinal shivering. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ondansetronAlso: Serotonin type 3 receptor antagonist8 mg ondansetron administered intravenously as a single dose five minutes after spinal anesthesia. | Drug | Group Ondansetron |
| Ketamine (0.25 mg/kg)Also: N-methyl-D-aspartate receptor antagonist0.25 mg per kilogram ketamine administered intravenously as a single dose five minutes after spinal anesthesia. | Drug | Group Low Dose Ketamine |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adeel Ahmed principal investigator
Mayo Hospital Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ondansetron and Ketamine (0.25 mg/kg) in people with Postoperative Shivering and Postspinal Shivering, run by Mayo Hospital Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.