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NCT Number: NCT07332806

Site of Tracheal Extubation and Operating Room Efficiency During Robot-assisted Surgery

This study aims to evaluate the impact of different extubation strategy on the occupancy time of operating room (OR) and the incidence of adverse events and quality of recovery after robotic-assisted surgery. The investigators hypothesize that extubation in the post-anesthesia care unit (PACU) may reduce OR occupancy time without increasing adverse events or worsening quality of recovery early after robotic-assisted surgery. This strategy may enhance perioperative efficiency while maintaining clinical safety.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Major surgeries are generally performed under general anesthesia with endotracheal tube. Intubation during anesthesia induction and extubation during anesthesia emergence are two high-risk periods associated with anesthesia-related complications. In clinical practice, extubation is performed either in the OR or in the PACU, according to local routine.

Robotic-assisted surgery offers potential clinical benefits but involves high costs and limited resource availability, making operating room (OR) efficiency a critical priority. While extubation in the post-anesthesia care unit (PACU) has been suggested to improve OR turnover, evidence regarding its impact on perioperative efficiency and safety compared to standard OR extubation in robotic surgery is limited.

The investigators hypothesize that extubation in the post-anesthesia care unit (PACU) may reduce OR occupancy time without increasing adverse events or worsening quality of recovery early after robotic-assisted surgery. This study aims to evaluate the impact of different extubation strategy on the occupancy time of operating room (OR) and the incidence of adverse events and quality of recovery after robotic-assisted surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged ≥18 years;
  • Scheduled to undergo elective robot-assisted laparoscopic surgery under general anesthesia;
  • Expected tracheal extubation during daytime working hours (before 4:00 PM).

Exclusion criteria

  • Refuse to participate in the study;
  • Morbid obesity (body mass index ≥35 kg/m²);
  • Preoperatively diagnosed obstructive sleep apnea, or patients with a STOP-Bang score ≥3 in combination with serum bicarbonate (HCO₃-) ≥28 mmol/L;
  • Patients at high risk of difficult airway (anticipated difficult intubation and/or extubation during preoperative assessment);
  • Preexisting sick sinus syndrome, severe sinus bradycardia (heart rate < 50 beats/min), or second-degree or higher atrioventricular block without pacemaker implantation; congenital heart disease with any type of arrhythmia; or other severe cardiovascular diseases with New York Heart Association (NYHA) functional class ≥III;
  • Significant pulmonary function impairment (FEV₁/FVC ratio < 70%, and total lung capacity [TLC] and vital capacity [VC] < 80% of predicted values);
  • Severe hepatic dysfunction (Child-Pugh class C); severe renal dysfunction (estimated glomerular filtration rate < 30 mL/min/1.73 m²); or American Society of Anesthesiologists (ASA) physical status classification ≥IV;
  • Preoperative diagnoses of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis;
  • Inability to communicate due to coma, severe dementia, or language impairment;
  • Planned postoperative admission to the intensive care unit;
  • Any other conditions that are deemed for study participation.

Treatment and study plan

Extubation in post-anesthesia care unit (PACU)

Procedure

At the end of surgery, patients will be transfered from OR to PACU with endotracheal intubation and then extubated in PACU.

Other names: PACU extubation

Extubation in operating room (OR)

Procedure

At the end of surgery, patients will be extubated in OR and then transfered from OR to PACU.

Other names: OR extubation

Primary outcomes

  1. Operating room (OR) occupancy time

    Time frame: Up to 2 hours after surgery

    Time interval from end of surgery to leaving OR for PACU.

Secondary outcomes

  1. Incidence of emergence delirium

    Time frame: Up to 3 hours after surgery

    Emergence delirium will be assessed with the confusion assessment method for the intensive care unit (CAM-ICU).

  2. Incidence of adverse events before leaving PACU

    Time frame: Up to 3 hours after surgery

    An adverse event indicates any unpredictable, unfavourable medical event that is associated with any medical intervention and occurs from end of surgery to the timepoint of leaving PACU.

  3. Time interval from end of surgery to modified Aldrete score of ≥9

    Time frame: Up to 3 hours after surgery

    Modified Aldrete Score is used to assess post-anesthesia recovery in five aspects (activity, respiration, circulation, consciousness, and oxygenation); scores range from 0 to 10, with higher scores indicating better recovery. A score of ≥9 indicates that patients can be safely transferred from PACU to general wards.

  4. Time interval from end of surgery to PACU discharge

    Time frame: Up to 2 hours after surgery

    Time interval from end of surgery to PACU discharge.

Other outcomes

  1. Time interval from end of surgery to extubation

    Time frame: Up to 3 hours after surgery

    Time interval from end of surgery to extubation.

  2. Turnover time in the operating room

    Time frame: Up to 3 hours after surgery

    Time interval between leaving OR of the last patient and entering OR of the next patient.

  3. Ready for surgery time in the operating room

    Time frame: Up to 3 hours after surgery

    Time interval between end of surgry of the last patient and ready for surgery of the next patient.

  4. Quality of recovery on postoperative day 1

    Time frame: At 24 hours after surgery

    Quality of recovery (QoR) will be assessed using the QoR-15. QoR-15 is a 15-item scale that assesses quality of postoperative recovery in 5 domains including pain, physical comfort, physiological independence, psychological state, and support and communication. Scores range from 0 to 150, with higher scores indicating better recovery.

  5. Length of hospital stay (LOS) after surgery

    Time frame: Up to 30 days after surgery

    Length of hospital stay (LOS) after surgery.

  6. 30-day all-cause mortality

    Time frame: Up to 30 days after surgery

    30-day all-cause mortality

  7. Incidence of postoperative complications within 30 days

    Time frame: Up to 30 days after surgery

    Postoperative complications indicate any new-onset medical events that are deemed harmful and require therateutic intervention, i.e., grade 2 or higher on the Clavien-Dindo classification (grades range from I to V, with higher grade indicating more severe complications).

  8. Total costs during hospitalization

    Time frame: Up to 30 days after surgery.

    Total costs during hospitalization

Study contacts

Contact information is provided by the study sponsor or research team.

Dong-Xin Wang, MD, PhD

CONTACT

[email protected]

01083572784

Ting Ding, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

Impact of Site of Tracheal Extubation on Operating Room Efficiency During Robot-assisted Surgery: a Randomized Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 12, 2026
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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