Analgesia Effects of Intravenous Ketamine After Spinal Anesthesia for Non-elective Cesarean Section
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ClinicalTrials.gov Identifier: NCT03450499 |
Recruitment Status :
Completed
First Posted : March 1, 2018
Last Update Posted : August 20, 2019
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Sponsor:
B.P. Koirala Institute of Health Sciences
Information provided by (Responsible Party):
prahlad adhikari, B.P. Koirala Institute of Health Sciences
Tracking Information | |||||
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First Submitted Date ICMJE | February 18, 2018 | ||||
First Posted Date ICMJE | March 1, 2018 | ||||
Last Update Posted Date | August 20, 2019 | ||||
Actual Study Start Date ICMJE | April 1, 2018 | ||||
Actual Primary Completion Date | March 7, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Total opioid requirement postoperatively [ Time Frame: 24 hrs ] Total opioid required up to 24 postoperatively in ketamine and placebo group.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Analgesia Effects of Intravenous Ketamine After Spinal Anesthesia for Non-elective Cesarean Section | ||||
Official Title ICMJE | Analgesia Effects of Intravenous Ketamine After Spinal Anesthesia for Non-elective Cesarean Section | ||||
Brief Summary | This randomized double blind study will be conducted in pregnant woman planned for non elective cesarean section under spinal anesthesia. Ketamine group will receive intravenous 0.25 mg/kg and placebo group will receive same amount of normal saline after spinal anesthesia prior to skin incision. Postoperative outcomes measures are total opioid consumption and pain scores for 24 hrs. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 4 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Non Elective Cesarean Section and Ketamine Analgesia | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
80 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | March 7, 2019 | ||||
Actual Primary Completion Date | March 7, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 35 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Nepal | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03450499 | ||||
Other Study ID Numbers ICMJE | IRC/1089/017 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | prahlad adhikari, B.P. Koirala Institute of Health Sciences | ||||
Study Sponsor ICMJE | B.P. Koirala Institute of Health Sciences | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | B.P. Koirala Institute of Health Sciences | ||||
Verification Date | August 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |