Non Elective Cesarean Section and Ketamine Analgesia Clinical Trial
Official title:
Analgesia Effects of Intravenous Ketamine After Spinal Anesthesia for Non-elective Cesarean Section
| Verified date | August 2019 |
| Source | B.P. Koirala Institute of Health Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | March 7, 2019 |
| Est. primary completion date | March 7, 2019 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 35 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Nepal | BP Koirala Institute of Health Sciences (BPKIHS) | Dharan Bazar | Koshi |
| Lead Sponsor | Collaborator |
|---|---|
| B.P. Koirala Institute of Health Sciences |
Nepal,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Total opioid requirement postoperatively | Total opioid required up to 24 postoperatively in ketamine and placebo group. | 24 hrs | |
| Secondary | Postoperative numerator rating scores(NRS)up to 24 hrs . postoperative ) | • Postoperative NRS Scores (on arrival to Post operative care unit), 2, 4, 6, 8, 12 and 24 h ).The NRS ranges from 0- 10 and 0 refers to no pain and 10 means extreme possible pain perceived. | 24 hrs | |
| Secondary | Time to first perception of pain | Time to first perception of pain | 24 hrs | |
| Secondary | Incidence of side effects | Incidence of post operative nausea and vomiting, shivering, sedation scores, side effects related to ketamine during the first 24h | 24 hrs |