NCT03806374

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

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

January 2, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 11, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 16, 2019

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

11 months

First QC Date

December 11, 2018

Last Update Submit

January 15, 2019

Conditions

Anesthesia

Keywords

fentanyllidocaineketamineinduction of anesthesiaintubation

Outcome Measures

Primary Outcomes (4)

  • Intubation with less hemodynamic changes

    changes in blood pressure with intubation

    15 minutes after induction of anesthesia.

  • Smooth Maintenance of anesthesia

    changes in blood pressure during anesthesia

    anesthesia time

  • less postoperative pain killers

    amount of pain killers used and timing

    24 hours postoperative

  • Intubation with less hemodynamic changes

    changes in pulse rate during anesthesia

    Anesthesia time

Study Arms (2)

Fentanyl

ACTIVE COMPARATOR

Administered propofol and fentanyl for induction.

Drug: PropofolDrug: FentanylDrug: Cisatracurium

Ketamine and lidocaine

ACTIVE COMPARATOR

Administered propofol, ketamine and lidocaine for induction.

Drug: KetamineDrug: PropofolDrug: CisatracuriumDrug: Lidocaine

Interventions

KetamineDRUG

ketamine

Ketamine and lidocaine
PropofolDRUG

propofol

FentanylKetamine and lidocaine
FentanylDRUG

fentanyl

Fentanyl
CisatracuriumDRUG

cisatracurium

FentanylKetamine and lidocaine
LidocaineDRUG

lidocaine

Ketamine and lidocaine

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University hospitals

Cairo, Egypt

Location

MeSH Terms

Interventions

KetaminePropofolFentanylcisatracuriumLidocaine

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPhenolsBenzene DerivativesHydrocarbons, AromaticPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAcetanilidesAnilidesAmidesAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

December 11, 2018

First Posted

January 16, 2019

Study Start

January 2, 2018

Primary Completion

December 1, 2018

Study Completion

December 10, 2018

Last Updated

January 16, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)