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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University First Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Extubation in post-anesthesia care unit (PACU)

    Procedure/Surgery

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

  • Extubation in operating room (OR)

    Procedure/Surgery

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

Treatment groups

218 Participants
are divided into 2 treatment groups
Group A: Extubation in post-anesthesia care unit (PACU)Experimental treatment 1 intervention
Group B: Extubation in operating room (OR)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Operating room (OR) occupancy time

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

Time frame
Up to 2 hours after surgery

Secondary outcomes

1

Incidence of emergence delirium

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

Time frame
Up to 3 hours after surgery
2

Incidence of adverse events before leaving PACU

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.

Time frame
Up to 3 hours after surgery
3

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

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.

Time frame
Up to 3 hours after surgery
4

Time interval from end of surgery to PACU discharge

Time interval from end of surgery to PACU discharge.

Time frame
Up to 2 hours after surgery

Other outcomes

1

Time interval from end of surgery to extubation

Time interval from end of surgery to extubation.

Time frame
Up to 3 hours after surgery
2

Turnover time in the operating room

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

Time frame
Up to 3 hours after surgery
3

Ready for surgery time in the operating room

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

Time frame
Up to 3 hours after surgery
4

Quality of recovery on postoperative day 1

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.

Time frame
At 24 hours after surgery

Sponsors and contacts

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