Skip to content

Analgesia Effects of Intravenous Ketamine After Spinal Anesthesia for Non-elective Cesarean Section

Analgesia Effects of Intravenous Ketamine After Spinal Anesthesia for Non-elective Cesarean Section

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03450499
Enrollment
80
Registered
2018-03-01
Start date
2018-04-01
Completion date
2019-03-07
Last updated
2019-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Elective Cesarean Section and Ketamine Analgesia

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.

Interventions

DRUGKetamine

the analgesic affects of ketamine will be compared between the experimental and placebo group.

DRUGPlacebo

the analgesic requirement will be calculated in placebo group.

Sponsors

B.P. Koirala Institute of Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Total opioid requirement postoperatively24 hrsTotal opioid required up to 24 postoperatively in ketamine and placebo group.

Secondary

MeasureTime frameDescription
Postoperative numerator rating scores(NRS)up to 24 hrs . postoperative )24 hrs• 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.
Time to first perception of pain24 hrsTime to first perception of pain
Incidence of side effects24 hrsIncidence of post operative nausea and vomiting, shivering, sedation scores, side effects related to ketamine during the first 24h

Countries

Nepal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026