Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03450499
Recruitment Status : Completed
First Posted : March 1, 2018
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
prahlad adhikari, B.P. Koirala Institute of Health Sciences

Tracking Information
First Submitted Date  ICMJE February 18, 2018
First Posted Date  ICMJE March 1, 2018
Last Update Posted Date August 20, 2019
Actual Study Start Date  ICMJE April 1, 2018
Actual Primary Completion Date March 7, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2018)
Total opioid requirement postoperatively [ Time Frame: 24 hrs ]
Total opioid required up to 24 postoperatively in ketamine and placebo group.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2018)
  • 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.
  • Time to first perception of pain [ Time Frame: 24 hrs ]
    Time to first perception of pain
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2018)
  • 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.
  • Time to first opioid request [ Time Frame: 24 hrs ]
    Time to first opioid request
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Analgesia Effects of Intravenous Ketamine After Spinal Anesthesia for Non-elective Cesarean Section
Official Title  ICMJE Analgesia Effects of Intravenous Ketamine After Spinal Anesthesia for Non-elective Cesarean Section
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Non Elective Cesarean Section and Ketamine Analgesia
Intervention  ICMJE
  • Drug: Ketamine
    the analgesic affects of ketamine will be compared between the experimental and placebo group.
    Other Name: ketamine hydrochloride
  • Drug: Placebo
    the analgesic requirement will be calculated in placebo group.
Study Arms  ICMJE
  • Experimental: analgesic effects of ketamine
    the experimental group will receive ketamine intravenously at 0.25 mg per kg before skin incision.
    Intervention: Drug: Ketamine
  • Placebo Comparator: placebo
    they will receive same volume of 0.9% normal saline as calculated for experimental group before skin incision.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 28, 2018)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 7, 2019
Actual Primary Completion Date March 7, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Nepal
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03450499
Other Study ID Numbers  ICMJE IRC/1089/017
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party prahlad adhikari, B.P. Koirala Institute of Health Sciences
Study Sponsor  ICMJE B.P. Koirala Institute of Health Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account B.P. Koirala Institute of Health Sciences
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP