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Trial record 6 of 838 for:    Ketamine

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

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ClinicalTrials.gov Identifier: NCT03450499
Recruitment Status : Recruiting
First Posted : March 1, 2018
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
prahlad adhikari, B.P. Koirala Institute of Health Sciences

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.

Condition or disease Intervention/treatment Phase
Non Elective Cesarean Section and Ketamine Analgesia Drug: Ketamine Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Analgesia Effects of Intravenous Ketamine After Spinal Anesthesia for Non-elective Cesarean Section
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: analgesic effects of ketamine
the experimental group will receive ketamine intravenously at 0.25 mg per kg before skin incision.
Drug: Ketamine
the analgesic affects of ketamine will be compared between the experimental and placebo group.
Other Name: ketamine hydrochloride

Placebo Comparator: placebo
they will receive same volume of 0.9% normal saline as calculated for experimental group before skin incision.
Drug: Placebo
the analgesic requirement will be calculated in placebo group.




Primary Outcome Measures :
  1. Total opioid requirement postoperatively [ Time Frame: 24 hrs ]
    Total opioid required up to 24 postoperatively in ketamine and placebo group.


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03450499


Contacts
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Contact: prahlad adhikari, graduate 9779851228244 pra_adhikari@hotmail.com

Locations
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Nepal
BP Koirala Institute of Health Sciences (BPKIHS) Recruiting
Dharān Bāzār, Koshi, Nepal, 56700
Contact: Prahlad Adhikari, MD         
Sponsors and Collaborators
B.P. Koirala Institute of Health Sciences

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Responsible Party: prahlad adhikari, doctor, B.P. Koirala Institute of Health Sciences
ClinicalTrials.gov Identifier: NCT03450499     History of Changes
Other Study ID Numbers: IRC/1089/017
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action