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

B

B.P. Koirala Institute of Health Sciences

Status and phase

Completed
Phase 4

Conditions

Non Elective Cesarean Section and Ketamine Analgesia

Treatments

Drug: Ketamine
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03450499
IRC/1089/017

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

80 participants in 2 patient groups, including a placebo group

analgesic effects of ketamine
Experimental group
Description:
the experimental group will receive ketamine intravenously at 0.25 mg per kg before skin incision.
Treatment:
Drug: Ketamine
placebo
Placebo Comparator group
Description:
they will receive same volume of 0.9% normal saline as calculated for experimental group before skin incision.
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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