Is it Possible to Replace Fentanyl in Anesthesia for Minor Procedures?

January 15, 2019 updated by: Ayman Anis Metry, Ain Shams University

Is it Possible to Replace Fentanyl by Non Narcotic Medication for Induction and Maintenance of Anesthesia in Minor Procedures?

To compare between fentanyl group and ketamine lidocaine group for induction of anesthesia as regards hemodynamics and smooth intubation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Two groups each with 60 patients Group I anesthesia initiated by propofol, fentanyl and cisatracurium. Group II anesthesia initiated by ketamine, lidocaine, propofol and cisatracurium.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain shams university hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA I and II between
  • Age between 18-55 years
  • Undergoing minor surgical procedure less than an hour.

Exclusion Criteria:

  • Patients with hypertension
  • Patients with Ischemic heart diseases
  • Patients with chronic renal or liver diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Fentanyl
Administered propofol and fentanyl for induction.
Drug: Propofol
propofol
Drug: Fentanyl
fentanyl
Drug: Cisatracurium
cisatracurium
ACTIVE_COMPARATOR: Ketamine and lidocaine
Administered propofol, ketamine and lidocaine for induction.
Drug: Propofol
propofol
Drug: Cisatracurium
cisatracurium
Drug: Ketamine
ketamine
Drug: Lidocaine
lidocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intubation with less hemodynamic changes
Time Frame: 15 minutes after induction of anesthesia.
changes in blood pressure with intubation
15 minutes after induction of anesthesia.
Smooth Maintenance of anesthesia
Time Frame: anesthesia time
changes in blood pressure during anesthesia
anesthesia time
less postoperative pain killers
Time Frame: 24 hours postoperative
amount of pain killers used and timing
24 hours postoperative
Intubation with less hemodynamic changes
Time Frame: Anesthesia time
changes in pulse rate during anesthesia
Anesthesia time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 2, 2018

Primary Completion (ACTUAL)

December 1, 2018

Study Completion (ACTUAL)

December 10, 2018

Study Registration Dates

First Submitted

December 11, 2018

First Submitted That Met QC Criteria

January 15, 2019

First Posted (ACTUAL)

January 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 16, 2019

Last Update Submitted That Met QC Criteria

January 15, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASUH9418

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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