Ability to Maintain Saturation Levels Without Oxygen Supplementation as a Extubation Criteria Without TOF Monitoring Equipment

Summary

Patients undergoing general anesthesia will have an endotracheal tube inserted. Adequate muscle strength recovery in the recovery room is crucial to ensure before extubation. One of the criteria we use to determine the recovery of muscle strength post-use of muscle relaxants in conditions without specific monitoring devices is the ability to maintain body oxygen levels without oxygen assistance for 3 minutes. This study aims to determine the muscle strength value in the recovery room using extubation strategies without muscle strength monitoring compared to extubation strategies with muscle strength monitoring.

Conditions

• Anesthesia Intubation Complication

Interventions

DEVICE

Train of four monitoring device intraoperative

Only group B will receive reversal strategy based on the presence of TOF monitoring device prior to extubation. If they meet the criteria, patients will then be extubated.

DRUG

Neostigmine

For subjects in Group A, the first researcher calculated the time of the last administration of the muscle relaxant and the subject's spontaneous breathing efforts. Neostigmine was administered based on the reversal protocol. For subjects in the TOF monitoring group (Group B), the first researcher attached the TOF monitoring device. After it was attached and turned on, TOF stimulation was provided without calibration, with a stimulation intensity of 50 mA. Measurements were taken in a 12-second cycle mode. Neostigmine was administered according to the measured TOF value at the start of skin/muscle closure as the protocol.

PROCEDURE

Air chalenge prior to extubation

After surgery was completed and the TOF ratio was ≥ 0.90, the TOF device was removed, and extubation was performed in Group B. In Group A, after a minimum of 15 minutes following reversal, patients received only ambient air without supplemental O2. Extubation was performed if the patient could maintain an SpO2 \> 95% for a minimum of 3 minutes. If within 15 minutes after reversal the patient did not meet the extubation criteria, the degree of blockade was reassessed, and a repeat dose of neostigmine and atropine was administered as needed. If there was suspicion of opioid-induced hypoventilation, naloxone was administered at 0.4-0.8 mcg intravenously.If the patient was unable to maintain oxygen saturation for the 3-minute duration, oxygen supplementation was reinstated, the degree of blockade was reassessed, and a repeat dose of neostigmine and atropine was administered as needed.

DEVICE

Train of Four monitoring device in recovery room

Upon arrival in the recovery room, all subjects were fitted with SpO2, EKG, NIBP monitors, and the TOF monitoring device. TOF values were measured by a second researcher who was unaware of the type of intervention. Measurements were taken twice sequential

Sponsors & Collaborators

• Anesthesiology and Intensive Therapy, Faculty of Medicine, Universitas Gadjah Mada

  collaborator UNKNOWN

• University of Surabaya

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-01

Primary Completion

2024-12-01

Completion

2026-01-01

Countries

• Indonesia

Study Locations