Controlled Ventilation During Anesthetic Emergence

NCT07853547 | Completed DMC

• 1 other identifier: ICT22J/002/01
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Absolutely - for a \*\*ClinicalTrials.gov-style Brief Summary\*\*, I'd keep it simple and patient-friendly like your example: The goal of this clinical trial is to learn whether maintaining controlled mechanical ventilation during emergence from general anesthesia can improve the quality and safety of recovery compared with conventional supported weaning in adults undergoing surgery with a breathing tube. The main questions it aims to answer are:

• Does controlled mechanical ventilation during emergence reduce coughing and the duration of coughing before removal of the breathing tube?
• Does it reduce agitation during emergence from anesthesia?
• Does it reduce the need for breathing support, such as continuous positive airway pressure (CPAP), after removal of the breathing tube?
• Are there differences in oxygen levels, blood pressure, heart rate, airway complications, or the time required for removal of the breathing tube? Researchers will compare controlled mechanical ventilation with conventional supported weaning during emergence from general anesthesia. Participants will:
• Receive general anesthesia with a breathing tube for their planned surgery
• Be assigned to either controlled mechanical ventilation or conventional supported weaning during emergence from anesthesia
• Have their coughing, agitation, oxygen levels, blood pressure, heart rate, and airway-related events monitored during emergence
• Have the time to removal of the breathing tube and any need for additional breathing support recorded This version is deliberately written in \*\*plain language rather than manuscript language\*\*, which is much closer to what ClinicalTrials.gov expects for the brief summary.

Conditions

Ventilation, Mechanical; Emergence From Anesthesia

Keywords

anesthesia recovery period; airway extubation; cough; emergence agitation; mechanical ventilation; pressure support ventilation; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Number of Coughing or Bucking Episodes During Emergence From General Anesthesia

  The number of coughing or bucking episodes was recorded during emergence from general anesthesia while the endotracheal tube remained in place. The outcome was compared between participants receiving conventional supported weaning and those maintained on controlled or full-support mechanical ventilation. A lower number of coughing or bucking episodes represented less airway reactivity during emergence.

  From discontinuation of sevoflurane until removal of the endotracheal tube, approximately 10 to 15 minutes.

Study Arms (2)

standard emergence group

NO INTERVENTION

At the end of surgery, sevoflurane was discontinued, FiO₂ was increased to 1.0, and oropharyngeal suctioning was performed. In the standard group, patients transitioned to conventional supported/spontaneous weaning using continuous positive airway pressure (CPAP) plus pressure support ventilation (PSV), PSV alone, or synchronized intermittent mandatory ventilation (SIMV), according to routine anesthesiologist practice. Fresh gas flow was 10-15 L/min until the end-tidal sevoflurane concentration reached approximately 0.2%. When end-tidal sevoflurane was approximately 0.2%, TOF ratio was ≥0.9, and BIS/Entropy was 80-100, the patient was called by name. Tracheal e

controlled-ventilation

EXPERIMENTAL

Participants assigned to the intervention arm were maintained on controlled or full-support mechanical ventilation during emergence from general anesthesia rather than transitioning to conventional supported or spontaneous weaning. Ventilation modes included pressure-controlled ventilation (PCV), pressure-controlled ventilation-volume guaranteed (PCV-VG), synchronized intermittent mandatory ventilation (SIMV), and volume-controlled ventilation (VCV), with a target respiratory rate of 12 to 16 breaths per minute. Fresh gas flow was maintained at 10 to 15 L/min until end-tidal sevoflurane reached approximately 0.2 percent. Extubation was performed when the train-of-four ratio was at least 0.9, BIS or Entropy was 80 to 100, the participant opened the eyes in response to being called by name, and the attending anesthesiologist judged awake extubation to be appropriate.

Device: Controlled/Full-Support Mechanical Ventilation During Emergence

Interventions

Controlled/Full-Support Mechanical Ventilation During Emergence DEVICE

Participants assigned to the intervention arm were maintained on controlled or full-support mechanical ventilation during emergence from general anesthesia rather than transitioning to conventional supported or spontaneous weaning. Ventilation modes included pressure-controlled ventilation (PCV), pressure-controlled ventilation-volume guaranteed (PCV-VG), synchronized intermittent mandatory ventilation (SIMV), and volume-controlled ventilation (VCV), with a target respiratory rate of 12 to 16 breaths per minute. Fresh gas flow was maintained at 10 to 15 L/min until end-tidal sevoflurane reached approximately 0.2 percent. Extubation was performed when the train-of-four ratio was at least 0.9, BIS or Entropy was 80 to 100, the participant opened the eyes in response to being called by name, and the attending anesthesiologist judged awake extubation to be appropriate.

controlled-ventilation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I-II, body mass index (BMI) \<35 kg/m², and no history of obstructive sleep apnea.

You may not qualify if:

• pregnancy, psychiatric illness, obstructive sleep apnea, and anticipated difficult airway.

Sponsors & Collaborators

• King Abdulaziz Medical City: lead

Study Sites (1)

king Abdulaziz Medical City

Riyadh, 11551, Saudi Arabia

Location

Related Publications (1)

• 1. Bhaskar SB. Emergence from anaesthesia: Have we got it all smoothened out? Indian J Anaesth. 2013;57:1-3. doi:10.4103/0019-5049.108549. 2. Tung A, Fergusson NA, Ng N, Hu V, Dormuth C, Griesdale DEG. Medications to reduce emergence coughing after general anaesthesia with tracheal intubation: a systematic review and network meta-analysis. Br J Anaesth. 2020;124:480-495. doi:10.1016/j.bja.2019.12.041. 3. Aouad MT, Zeeni C, Al Nawwar R, Siddik-Sayyid SM, Barakat HB, Elias S, et al. Dexmedetomidine for improved quality of emergence from general anesthesia: a dose-finding study. Anesth Analg. 2019;129:1504-1511. doi:10.1213/ANE.0000000000002763. 4. Kim H, Min KT, Lee JR, Ha SH, Lee WK, Seo JH, et al. Comparison of dexmedetomidine and remifentanil on airway reflex and hemodynamic changes during recovery after craniotomy. Yonsei Med J. 2016;57:980-986. doi:10.3349/ymj.2016.57.4.980. 5. Soh S, Park WK, Kang SW, Lee BR, Lee JR. Sex differences in remifentanil requirements for preventing cough during anesthetic emergence. Yonsei Med J. 2014;55:807-814. doi:10.3349/ymj.2014.55.3.807. 6. Choi EM, Park WK, Choi SH, Soh S, Lee JR. Smooth emergence in men undergoing nasal surgery: the effect site concentration of remifentanil for preventing cough after sevoflurane-balanced anaesthesia. Acta Anaesthesiol Scand. 2012;56:498-503. doi:10.1111/j.1399-6576.2011.02620.x. 7. Richardson PB, Krishnan S, Janakiraman C, Wilkes AR, Hodzovic I. Extubation after anaesthesia: a randomised comparison of three techniques. Acta Clin Croat. 2012;51:529-536. 8. Capdevila X, Jung B, Bernard N, Dadure C, Biboulet P, Jaber S, et al. Effects of pressure support ventilation mode on emergence time and intra-operative ventilatory function: a randomized controlled trial. PLoS One. 2014;9:e115139. doi:10.1371/journal.pone.0115139. 9. Jeong H, Tanatporn P, Ahn HJ, Yang M, Kim JA, Yeo H, et al. Pressure support versus spontaneous ventilation during anesthetic emergence-effect on postoperative atelectasis: a ra

  RESULT

MeSH Terms

Conditions

Respiratory Aspiration; Cough; Emergence Delirium

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesilogist

Study Record Dates

• First Submitted: September 26, 2026
• First Posted: October 1, 2026
• Study Start: August 17, 2024
• Primary Completion: March 2, 2025
• Study Completion: March 16, 2025
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available following publication of the study results and will remain available upon reasonable request, subject to applicable institutional, ethical, and data-sharing requirements.
• Access Criteria: De-identified individual participant data may be provided to qualified researchers who submit a reasonable research request to the corresponding author. Requests will be reviewed by the study investigators and, where applicable, the relevant institutional or ethics authorities. Data will be shared only for scientifically appropriate purposes and in accordance with institutional policies, participant confidentiality requirements, and any required data-use agreements.

Locations

SA (1)