Magnesium Versus High Dose Fentanyl in Endotracheal Intubation

NCT ID: NCT04544163

Last Updated: 2021-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-05

Study Completion Date

2021-05-05

Brief Summary

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

Detailed Description

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to assess the effect of MgSO4 combined with fentanyl compared to high dose fentanyl in attenuating stress response in cancer patients undergoing surgeries under general anesthesia requiring endotracheal intubation

Conditions

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Stress Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Magnesium sulphate- Fentanyl

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

Group Type EXPERIMENTAL

Magnesium sulfate- Fentanyl

Intervention Type DRUG

drug administration before intubation

Fentanyl 2Mcg/kg

Intervention Type DRUG

drug administration with induction of anesthesia

Fentanyl 4 mic

4 mic per kg fentanyl i.v

Group Type EXPERIMENTAL

Fentanyl 4Mcg/kg

Intervention Type DRUG

drug administration with induction of anesthesia

Fentanyl

2 mic per kg fentanyl i.v

Group Type ACTIVE_COMPARATOR

Fentanyl 2Mcg/kg

Intervention Type DRUG

drug administration with induction of anesthesia

Lidocaine- Fentanyl

Lidocaine 1.5 mg/kg

Group Type EXPERIMENTAL

Fentanyl 2Mcg/kg

Intervention Type DRUG

drug administration with induction of anesthesia

Lidocaine 1.5 mg/kg

Intervention Type DRUG

drug administaration 90 sec before intubation

Interventions

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Magnesium sulfate- Fentanyl

drug administration before intubation

Intervention Type DRUG

Fentanyl 4Mcg/kg

drug administration with induction of anesthesia

Intervention Type DRUG

Fentanyl 2Mcg/kg

drug administration with induction of anesthesia

Intervention Type DRUG

Lidocaine 1.5 mg/kg

drug administaration 90 sec before intubation

Intervention Type DRUG

Other Intervention Names

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MgSo4 high dose fentanyl Conventional anesthesia Lidocaine

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* allergy to any of the used drugs
* renal or hepatic impairment
* hypertensive patients, patients with cardiovascular or cerebrovascular diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Walaa Youssef Elsabeeny

Lecturer of anesthesia and pain management

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Walaa Y Elsabeeny, MD

Role: PRINCIPAL_INVESTIGATOR

Lecturer

Nahla N Shehab, MD

Role: PRINCIPAL_INVESTIGATOR

Lecturer

Locations

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Walaa Y Elsabeeny

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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AP2007-50108

Identifier Type: -

Identifier Source: org_study_id

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