NCT04544163

Brief Summary

this study is designed to assess the efficacy of MgSO4 versus high dose fentanyl compared to conventional anesthesia in attenuating stress response to intubation

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

September 3, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

September 5, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2021

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2021

Completed
Last Updated

May 11, 2021

Status Verified

May 1, 2021

Enrollment Period

8 months

First QC Date

September 3, 2020

Last Update Submit

May 8, 2021

Conditions

Stress Response

Outcome Measures

Primary Outcomes (1)

  • heart rate values

    changes in heart rate values after intubation

    5 minutes

Secondary Outcomes (2)

  • blood pressure

    5 minutes

  • coughing during intubation

    lntubation time

Study Arms (4)

Magnesium sulphate- Fentanyl

EXPERIMENTAL

30 mg per kg MgSo4 infusion in 100 ml saline over 10 minutes

Drug: Magnesium sulfate- FentanylDrug: Fentanyl 2Mcg/kg

Fentanyl 4 mic

EXPERIMENTAL

4 mic per kg fentanyl i.v

Drug: Fentanyl 4Mcg/kg

Fentanyl

ACTIVE COMPARATOR

2 mic per kg fentanyl i.v

Drug: Fentanyl 2Mcg/kg

Lidocaine- Fentanyl

EXPERIMENTAL

Lidocaine 1.5 mg/kg

Drug: Fentanyl 2Mcg/kgDrug: Lidocaine 1.5 mg/kg

Interventions

Magnesium sulfate- FentanylDRUG

drug administration before intubation

Also known as: MgSo4
Magnesium sulphate- Fentanyl
Fentanyl 4Mcg/kgDRUG

drug administration with induction of anesthesia

Also known as: high dose fentanyl
Fentanyl 4 mic
Fentanyl 2Mcg/kgDRUG

drug administration with induction of anesthesia

Also known as: Conventional anesthesia
FentanylLidocaine- FentanylMagnesium sulphate- Fentanyl
Lidocaine 1.5 mg/kgDRUG

drug administaration 90 sec before intubation

Also known as: Lidocaine
Lidocaine- Fentanyl

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Cancer patients undergoing surgery under general anesthesia requiring endotracheal intubation
  • ASA I II
  • to 60

You may not qualify if:

  • allergy to any of the used drugs
  • renal or hepatic impairment
  • hypertensive patients, patients with cardiovascular or cerebrovascular diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walaa Y Elsabeeny

Cairo, 11796, Egypt

Location

MeSH Terms

Conditions

Fractures, Stress

Interventions

FentanylLidocaine

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Walaa Y Elsabeeny, MD

    Lecturer

    PRINCIPAL INVESTIGATOR

  • Nahla N Shehab, MD

    Lecturer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia and pain management

Study Record Dates

First Submitted

September 3, 2020

First Posted

September 10, 2020

Study Start

September 5, 2020

Primary Completion

May 2, 2021

Study Completion

May 5, 2021

Last Updated

May 11, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share

data will be available upon reasonable request through contacting the corresponding author

Locations

EG(1)