Nalbuphine vs Ketamine for Peri-Operative Shivering Control
Summary
ClinicalTrials.gov registration NCT07543913 documents a randomized, two-arm Phase 4 study comparing intravenous nalbuphine versus ketamine at low doses for prevention and treatment of peri-operative shivering in patients undergoing gynecological surgery under spinal anesthesia. Participants will be assessed on shivering incidence, severity, complications (vomiting, sedation), and need for rescue medication. The trial is registered with an estimated completion date and is accessible via ClinicalTrials.gov.
“The use of opioids has shown effectiveness in treating shivering.”
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What changed
The ClinicalTrials.gov registration documents a randomized controlled trial comparing nalbuphine and ketamine for managing post-spinal anesthesia shivering in gynecological surgery patients. Two intervention arms are defined: participants receiving injection nalbuphine and participants receiving injection ketamine. The study will evaluate shivering incidence, severity, complications (vomiting, sedation), and rescue medication requirements.
For clinical investigators and research institutions, this registry entry provides advance notice of an upcoming comparative drug study in the peri-operative shivering space. Pharmaceutical companies with nalbuphine or ketamine products may track this study for post-marketing evidence development.
Archived snapshot
Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Comparison of Two Drugs ,i.e., Nalbuphine Vs Ketamine at Low Doses for the Peri-Operative Shivering Control in Patients Undergoing Gynaecological Surgery Under Spinal Anaesthesia
N/A NCT07543913 Kind: NA Apr 22, 2026
Abstract
Shivering is recognized as an undesirable effect of spinal anesthesia. Patients undergoing gynecological surgeries may experience increased physiological stress due to perioperative shivering. This condition can lead to serious complications such as increased oxygen consumption, resulting in hypoxemia, lactic acidosis, and elevated carbon dioxide production. Additionally, shivering may cause increased intraocular and intracerebral pressure and can interfere with monitoring techniques like pulse oximetry, blood pressure, and electrocardiography. If not treated, shivering can negatively impact patient outcomes, prolong recovery times, and extend hospital stays. The use of opioids has shown effectiveness in treating shivering. Based on the existing literature, it is hypothesized that there is no difference in the efficacy of nalbuphine and ketamine in controlling perioperative shivering in patients undergoing gynecological surgery under spinal anesthesia. Therefore, the study aims to investigate and compare the effectiveness of nalbuphine and ketamine in managing post-spinal shivering in these patients, focusing on i) incidence of shivering, ii) severity of shivering in both groups, iii) complications such as vomiting and sedation, and iv) the need for rescue medication. Preventing and managing shivering is crucial for successful surgical outcomes. To date, no comparative study has evaluated the intravenous efficacy of these two drugs in this patient population for post-spina...
Conditions: Peri-operative Shivering Under Spinal Anaesthesia
Interventions: Participants assigned to this arm received injection nalbuphine., Participants assigned to this arm received injection ketamine.
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