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Completed

NCT Number: NCT04281628

Comparison Between Low-dose Ketamine Infusion and Intravenous Morphine

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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine, Cairo University.

Cairo, 11451, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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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Treatment and study plan

Ketamine group:

Drug

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.

Control group

Drug

where normal saline was administered as a loading dose then infused with same rate of another group, throughout the whole surgery.

Primary outcomes

  1. 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.

Secondary outcomes

  1. duration of surgery

    Time frame: UP TO 1 HOURE

    time from start to end

  2. postoperative pain score

    Time frame: up to 24 hours

    assessment of patient by VAS sore 0= no pain , 10= sever pain

  3. Number of Participants with hallucinations

    Time frame: up to 24 hours

    complication

  4. Number of Participants with sleep disturbances

    Time frame: up to 24 hours

    complication

  5. Number of Participants with nausea and vomiting

    Time frame: up to 24 hour

    complication

  6. Number of Participants with sedation

    Time frame: up to 24 hour

    complication

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Comparison Between Low-dose Ketamine Infusion and Intravenous Morphine Infusion for Analgesia in Laparotomy Myomectomy: A Double-blind, Randomized, Controlled Clinical Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 24, 2020
Registry last updated
Jul 30, 2020

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.

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