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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03450499 |
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Date of registration:
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18/02/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Analgesia Effects of Intravenous Ketamine After Spinal Anesthesia for Non-elective Cesarean Section
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Scientific title:
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Analgesia Effects of Intravenous Ketamine After Spinal Anesthesia for Non-elective Cesarean Section |
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Date of first enrolment:
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April 1, 2018 |
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Target sample size:
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80 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03450499 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 4
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Countries of recruitment
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Nepal
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- • All women at term(>or =37 weeks of gestation)
- Healthy
- American Society of Anesthesiologists(ASA) class1 and 2
- Women undergoing non-elective caesarean section whose anesthetic plan is for
spinal anesthesia with bupivacaine and fentanyl
Exclusion Criteria:
- • Women with American society of anesthesiologist physical status>2
- Body mass index >or =40 kg per square meter
- Height <150 cm
- Any contraindication to the spinal anesthesia
- History of substance abuse
- History of hallucinations
- Chronic opioid therapy
- Chronic pain or on any pain medication currently
- Patient with maternal complications,like cardiovascular disease
pre-eclampsia,diabetes,multiple gestation,known fetal abnormality
- Cases with severely compromised fetus where immediate administration of general
anesthesia is required.
Age minimum:
18 Years
Age maximum:
35 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Non Elective Cesarean Section and Ketamine Analgesia
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Intervention(s)
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Drug: Ketamine
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Drug: Placebo
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Primary Outcome(s)
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Total opioid requirement postoperatively
[Time Frame: 24 hrs]
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Secondary Outcome(s)
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Time to first perception of pain
[Time Frame: 24 hrs]
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Postoperative numerator rating scores(NRS)up to 24 hrs . postoperative )
[Time Frame: 24 hrs]
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Incidence of side effects
[Time Frame: 24 hrs]
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Secondary ID(s)
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IRC/1089/017
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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