Intubation Conditions After RSI Using Rocuronium with Ephedrine Pretreatment

NCT ID: NCT05725031

Last Updated: 2024-10-15

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

PHASE3

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2024-03-01

Brief Summary

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This trial will study if ephedrine pretreatment before low doses of rocuronium (0.6 or 0.8 mg/kg) would provide similar intubating conditions as with the high dose of 1.2 mg/kg in patients undergoing RSII.

Detailed Description

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Conditions

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Rapid Sequence Induction and Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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ER6

to receive rocuronium 0.6 mg/kg with ephedrine pretreatment

Group Type EXPERIMENTAL

Ephedrine

Intervention Type DRUG

70 μg/kg as pretreatment

Rocuronium 0.6

Intervention Type DRUG

0.6 mg/kg

ER8

to receive rocuronium 0.8 mg/kg with ephedrine pretreatment

Group Type EXPERIMENTAL

Ephedrine

Intervention Type DRUG

70 μg/kg as pretreatment

Rocuronium 0.8

Intervention Type DRUG

0.8 mg/kg

R12

to receive rocuronium 1.2 mg/kg with no pretreatment

Group Type ACTIVE_COMPARATOR

Rocuronium 1.2

Intervention Type DRUG

1.2 mg/kg

Interventions

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Ephedrine

70 μg/kg as pretreatment

Intervention Type DRUG

Rocuronium 0.6

0.6 mg/kg

Intervention Type DRUG

Rocuronium 0.8

0.8 mg/kg

Intervention Type DRUG

Rocuronium 1.2

1.2 mg/kg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ASA physical status I or II

Exclusion Criteria

* Neuromuscular disease: myopathies
* On drugs that interact with the neuromuscular junction or ephedrine
* Cardiovascular disease: hypertension or ischemic heart disease
* Increased risk of pulmonary aspiration:

* GERD
* Pregnancy
* Anticipated airway difficulties:

* Mallampati grade III or IV
* Obesity (BMI ≥30 kg/m2),
* Hypersensitivity to any of the study drugs
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Amal Ahmed Eldemohi

Resident of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University Hospitals

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Eph-Roc

Identifier Type: -

Identifier Source: org_study_id

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