NCT04365686

Brief Summary

the effect of ketofol, a combination of propofol and ketamine, on hemodynamics and airway response during induction of general anesthesia has been studied before. Its effect on the smoothness of extubation has not been studied before. In the present study; we aimed to assess the effect of ketofol on the smoothness of extubation as regards, airway response, sedation score during suction and extubation and hemodynamic changes comparing it with propofol for induction of general anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2019

Shorter than P25 for phase_4

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 12, 2020

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
Last Updated

April 28, 2020

Status Verified

April 1, 2020

Enrollment Period

1 year

First QC Date

April 23, 2020

Last Update Submit

April 24, 2020

Conditions

Smooth Extubation

Keywords

KetofolPropofolLaparoscopic Drilling of Polycystic Ovary

Outcome Measures

Primary Outcomes (1)

  • smoothness of extubation

    Smoothness of extubation Grade Description 1. No coughing on endotracheal tube 2. Coughing on the tube 3. Vomiting 4. Laryngospasm

    5 minutes after extubation

Secondary Outcomes (18)

  • airway response to laryngoscopy and suction

    5 minutes after extubation

  • sedation score

    5 minutes after extubation

  • Age

    6 hours before intervention

  • weight

    6 hours before intervention

  • Height

    6 hours before intervention

  • +13 more secondary outcomes

Study Arms (2)

Group K

ACTIVE COMPARATOR

Ketofol group

Drug: Ketofol as induction agent

Group P

ACTIVE COMPARATOR

propofol group

Drug: Propofol as induction agent

Interventions

Ketofol as induction agentDRUG

Patients who received propofol (1mg/kg) plus ketamine (0.5mg/kg) at the induction of general anesthesia

Group K
Propofol as induction agentDRUG

Patients who received propofol (2mg/kg) only at the induction of general anesthesia.

Group P

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspatient with polycystic ovary.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiologists Physical status ''ASA PS'' class I and II scheduled for laparoscopic drilling for polycystic ovary under general anesthesia.

You may not qualify if:

  • from cardiac, hepatic, renal diseases, history of epilepsy
  • Patient refusal.
  • known drug allergy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fayoum University hospital

Al Fayyum, Madīnat Al Fayyūm, Faiyum Governorate, Egypt, 63514, Egypt

Location

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Atef S Khalil, MD

    Fayoum University Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

April 23, 2020

First Posted

April 28, 2020

Study Start

April 1, 2019

Primary Completion

April 12, 2020

Study Completion

April 20, 2020

Last Updated

April 28, 2020

Record last verified: 2020-04

Locations

EG(1)