Intubation Conditions After RSI Using Rocuronium With Ephedrine Pretreatment

Sponsor

Ain Shams University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05725031

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Rapid Sequence Induction and Intubation	Drug: Ephedrine Drug: Rocuronium 0.6 Drug: Rocuronium 0.8 Drug: Rocuronium 1.2	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Health Services Research

Official Title:

Intubation Conditions After Rapid Sequence Induction Using Different Doses of Rocuronium With Ephedrine Pretreatment: A Randomized Controlled Trial

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ER6 to receive rocuronium 0.6 mg/kg with ephedrine pretreatment	Drug: Ephedrine 70 μg/kg as pretreatment Drug: Rocuronium 0.6 0.6 mg/kg
Experimental: ER8 to receive rocuronium 0.8 mg/kg with ephedrine pretreatment	Drug: Ephedrine 70 μg/kg as pretreatment Drug: Rocuronium 0.8 0.8 mg/kg
Active Comparator: R12 to receive rocuronium 1.2 mg/kg with no pretreatment	Drug: Rocuronium 1.2 1.2 mg/kg

Arm

Intervention/Treatment

Experimental: ER6

to receive rocuronium 0.6 mg/kg with ephedrine pretreatment

Drug: Ephedrine

70 μg/kg as pretreatment

Drug: Rocuronium 0.6

0.6 mg/kg

Experimental: ER8

to receive rocuronium 0.8 mg/kg with ephedrine pretreatment

Drug: Ephedrine

70 μg/kg as pretreatment

Drug: Rocuronium 0.8

0.8 mg/kg

Active Comparator: R12

to receive rocuronium 1.2 mg/kg with no pretreatment

Drug: Rocuronium 1.2

1.2 mg/kg

Outcome Measures

Primary Outcome Measures

Intubation conditions [after 60 seconds of rocuronium administration]
Evaluation of intubation conditions after rapid sequence induction using rocuronium 0.6 or 0.8 mg/kg with ephedrine pretreatment, compared with 1.2 mg/kg, according to the criteria of the Good Clinical Research Practice (GCRP) in pharmacodynamic studies of NMBAs (Fuchs-Buder et al., 2007), which assess each of the following variables for their qualities described as: (excellent, good, poor) ease of laryngoscopy (easy, fair, difficult) vocal cords position (abducted, intermediate, closed) reaction to tracheal tube insertion and cuff inflation (coughing: none, slight, vigorous) The 3 variables will be combined to describe intubation conditions as: Excellent: if all qualities are excellent Good: if all qualities are either excellent or good Poor: if there is a single poor quality

Secondary Outcome Measures

Heart rate [every minute of the first 5 minutes of intubation]
Following up the heart rate on the monitor
Mean arterial pressure [every minute of the first 5 minutes of intubation]
Following up the mean arterial pressure by noninvasive blood pressure monitoring

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amal Ahmed Eldemohi, Resident of Anesthesiology, Ain Shams University

ClinicalTrials.gov Identifier:

NCT05725031

Other Study ID Numbers:

Eph-Roc

First Posted:

Feb 13, 2023

Last Update Posted:

Feb 14, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ephedrine

Rocuronium

Study Results

No Results Posted as of Feb 14, 2023