NCT04281628

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 21, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 24, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2020

Completed
Last Updated

July 30, 2020

Status Verified

July 1, 2020

Enrollment Period

1.2 years

First QC Date

February 20, 2020

Last Update Submit

July 28, 2020

Conditions

Ketamine

Keywords

KetamineMorphineLaparotomy Myomectomy

Outcome Measures

Primary Outcomes (1)

  • total Amount of Morphine need intraoperative and postoperative

    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.

    up to 24 hours

Secondary Outcomes (6)

  • duration of surgery

    UP TO 1 HOURE

  • postoperative pain score

    up to 24 hours

  • Number of Participants with hallucinations

    up to 24 hours

  • Number of Participants with sleep disturbances

    up to 24 hours

  • Number of Participants with nausea and vomiting

    up to 24 hour

  • +1 more secondary outcomes

Study Arms (2)

Control group

PLACEBO COMPARATOR

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

Drug: Control group

ketamine group

ACTIVE COMPARATOR

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: Ketamine group:

Interventions

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.

ketamine group
Control groupDRUG

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

Control group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsopration un female only
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Cairo University.

Cairo, 11451, Egypt

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • amr wahadan, MD

    lecture

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesia, Pain management and Surgical ICU

Study Record Dates

First Submitted

February 20, 2020

First Posted

February 24, 2020

Study Start

February 21, 2019

Primary Completion

May 20, 2020

Study Completion

June 20, 2020

Last Updated

July 30, 2020

Record last verified: 2020-07

Locations

EG(1)