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OpenTrials
Completed

NCT Number: NCT03450499

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

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.

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Key information

Conditions

Non Elective Cesarean Section and Ketamine Analgesia

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

BP Koirala Institute of Health Sciences (BPKIHS)

Dharān, Koshi, 56700, Nepal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ketamine

Drug

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

Other names: ketamine hydrochloride

Placebo

Drug

the analgesic requirement will be calculated in placebo group.

Primary outcomes

  1. Total opioid requirement postoperatively

    Time frame: 24 hrs

    Total opioid required up to 24 postoperatively in ketamine and placebo group.

Secondary outcomes

  1. Postoperative numerator rating scores(NRS)up to 24 hrs . postoperative )

    Time frame: 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.

  2. Time to first perception of pain

    Time frame: 24 hrs

    Time to first perception of pain

  3. Incidence of side effects

    Time frame: 24 hrs

    Incidence of post operative nausea and vomiting, shivering, sedation scores, side effects related to ketamine during the first 24h

Sponsors and collaborators

Lead sponsor

B.P. Koirala Institute of Health Sciences

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 1, 2018
Registry last updated
Aug 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.