A Study Comparing Clinical Assessment and Monitor-Based Methods for Guiding Muscle Relaxant Use During Elective Head and Neck Surgeries

A Comparative Study of Rocuronium Maintenance Dosing Guided by Capnography and Clinical Assessment versus Quantitative Monitoring Using Train-of-Four in Elective Head-and-Neck Surgeries - NIL

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/106469

Enrollment

100

Registered

2026-03-18

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J958- Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified

Interventions

Intervention1: Quantitative Assessment: Two surface electrodes for neuromuscular monitoring will be applied along the ulnar nerve at the wrist. The distal electrode will be positioned over the ulnar n

Eligibility

Inclusion criteria

Inclusion criteria: Patients classified into the ASA classes one to three Patients scheduled to undergo elective head and neck surgery Patients will be extubated in the operating theater Anticipated surgical duration of at least 90 minutes to allow for sufficient need for rocuronium redosing

Exclusion criteria

Exclusion criteria: Patient refusal for procedure. Patients classified into the ASA class four Patient with pre-existing neuromuscular disorder Known allergy to neuromuscular blocking agents Abnormal liver or kidney function Patient with BMI Greater than 25 kilogram per meter square Patients receiving medications known to interfere with neuromuscular blockade Patients with moderate to severe cardiac or respiratory disease that could affect intraoperative ventilatory parameters or hemodynamics history of malignant hyperthermia

Design outcomes

Primary

Measure	Time frame
To compare the total intraoperative maintenance dose mg per kg per min of rocuronium administered between the two groupsTimepoint: To compare the total intraoperative maintenance dose mg per kg per min of rocuronium administered between the two groups Outcome will be assessed only during intra operative time	—

Secondary

Measure	Time frame
To compare the time from the initial intubating dose to the administration of the first maintenance dose of rocuronium between the two groups To compare intraoperative ventilatory and hemodynamic parameters like peak pressure, tidal volume and heart rate between patients receiving rocuronium maintenance dosing guided by Clinical assessment, capnography and those guided by Train of four monitoringTimepoint: Outcome only assess during Intra Operative period	—

Measure

Time frame

To compare the time from the initial intubating dose to the administration of the first maintenance dose of rocuronium between the two groups To compare intraoperative ventilatory and hemodynamic parameters like peak pressure, tidal volume and heart rate between patients receiving rocuronium maintenance dosing guided by Clinical assessment, capnography and those guided by Train of four monitoringTimepoint: Outcome only assess during Intra Operative period

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Countries

India

Contacts

Public ContactDr Abhay Raj Yadav

AIIMS Raebareli

abhayrajkgmu@gmail.com9415017089

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026