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Comparison Between Low-dose Ketamine Infusion and Intravenous Morphine

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ClinicalTrials.gov Identifier: NCT04281628
Recruitment Status : Completed
First Posted : February 24, 2020
Last Update Posted : July 30, 2020
Sponsor:
Information provided by (Responsible Party):
Amr Samir Wahdan, Cairo University

Tracking Information
First Submitted Date  ICMJE February 20, 2020
First Posted Date  ICMJE February 24, 2020
Last Update Posted Date July 30, 2020
Actual Study Start Date  ICMJE February 21, 2019
Actual Primary Completion Date May 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2020)
total Amount of Morphine need intraoperative and postoperative [ Time Frame: up to 24 hours ]
adjusted to keep the HR and mean arterial blood pressure within 20% of the pre induction values. Starting from the induction till the end of the operation.
Original Primary Outcome Measures  ICMJE
 (submitted: February 21, 2020)
Amount of fentanyl need intraoperative [ Time Frame: UP TO 1 HOURE ]
adjusted to keep the HR and mean arterial blood pressure within 20% of the pre induction values. Starting from the induction till the end of the operation.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2020)
  • duration of surgery [ Time Frame: UP TO 1 HOURE ]
    time from start to end
  • postoperative pain score [ Time Frame: up to 24 hours ]
    assessment of patient by VAS sore 0= no pain , 10= sever pain
  • Number of Participants with hallucinations [ Time Frame: up to 24 hours ]
    complication
  • Number of Participants with sleep disturbances [ Time Frame: up to 24 hours ]
    complication
  • Number of Participants with nausea and vomiting [ Time Frame: up to 24 hour ]
    complication
  • Number of Participants with sedation [ Time Frame: up to 24 hour ]
    complication
Original Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2020)
  • duration of surgery [ Time Frame: UP TO 1 HOURE ]
    time from start to end
  • Ramsey Scale [ Time Frame: up to 24 hours ]
    assessment of patient sedation
  • Number of Participants with hallucinations [ Time Frame: up to 24 hours ]
    complication
  • Number of Participants with sleep disturbances [ Time Frame: up to 24 hours ]
    complication
  • Number of Participants with nausea and vomiting [ Time Frame: up to 24 hour ]
    complication
  • Number of Participants with sedation [ Time Frame: up to 24 hour ]
    complication
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison Between Low-dose Ketamine Infusion and Intravenous Morphine
Official Title  ICMJE Comparison Between Low-dose Ketamine Infusion and Intravenous Morphine Infusion for Analgesia in Laparotomy Myomectomy: A Double-blind, Randomized, Controlled Clinical Trial
Brief Summary Ketamine is an antagonist of N-methyl-d-aspartate (NMDA) receptor that not only abolishes peripheral afferent noxious stimulation, but it may also prevent central sensitization of nociceptors as shown in animal studies with excellent analgesic property even in subanesthetic doses. It is readily available and is being used currently, even by non-Anesthesiologists, to provide "sedation" for minor procedures.(.. Low-dose ketamine infusion in the perioperative period has shown to produce analgesia and decrease the requirements of opioid analgesics.. In obstetrics, it is being used as an adjunct to an inadequately functioning spinal anesthesia for caesarean section, as an induction agent for cesarean section and also to provide analgesia during labor in intermittent boluses.
Detailed Description Ketamine is an antagonist of N-methyl-d-aspartate (NMDA) receptor that not only abolishes peripheral afferent noxious stimulation, but it may also prevent central sensitization of nociceptors as shown in animal studies with excellent analgesic property even in subanesthetic doses. It is readily available and is being used currently, even by non-Anesthesiologists, to provide "sedation" for minor procedures.(.. Low-dose ketamine infusion in the perioperative period has shown to produce analgesia and decrease the requirements of opioid analgesics.. In obstetrics, it is being used as an adjunct to an inadequately functioning spinal anesthesia for caesarean section, as an induction agent for cesarean section and also to provide analgesia during labor in intermittent boluses.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Diagnostic
Condition  ICMJE Ketamine
Intervention  ICMJE
  • Drug: Ketamine group:
    Ketamine group: will be administered ketamine in a loading dose of 0.2 mg/kg over 5 min pre incision followed-by an infusion at 0.2 mg/kg/h until the end of surgery.
  • Drug: Control group
    where normal saline was administered as a loading dose then infused with same rate of another group, throughout the whole surgery.
Study Arms  ICMJE
  • Placebo Comparator: Control group
    control group: where normal saline will be administered as a loading dose then infused with same rate of another group, throughout the whole surgery.
    Intervention: Drug: Control group
  • Active Comparator: ketamine group
    Ketamine group: will be administered ketamine in a loading dose of 0.2 mg/kg over 5 min pre incision followed-by an infusion at 0.2 mg/kg/h until the end of surgery.
    Intervention: Drug: Ketamine group:
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 21, 2020)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 20, 2020
Actual Primary Completion Date May 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

The study will include 80 ASA physical status I, II patients with age between 18- 50 years old scheduled for elective myomectomy under general anesthesia

Exclusion criteria:

Patients who refused to participate, ASA physical status III, IV, patients younger than 18 years or > 50 years old, BMI > 30, history of epilepsy. Patients having a history of parenteral or oral analgesics within the last 24 hours before initiation of operation or those having allergy to study agents will be excluded.

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Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: opration un female only
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04281628
Other Study ID Numbers  ICMJE I-190414
Has Data Monitoring Committee Yes
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: Undecided
Plan Description: still working
Responsible Party Amr Samir Wahdan, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: amr wahadan, MD lecture
PRS Account Cairo University
Verification Date July 2020

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