Airway Extubation, Anesthesia Recovery Period, Operating Rooms, Postoperative Complications, Robotic Surgical Procedures
Conditions
Keywords
Robotic Surgical Procedures, Airway Extubation, Operating Rooms, Anesthesia Recovery Period, Postoperative Complications
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREExtubation in post-anesthesia care unit (PACU)
At the end of surgery, patients will be transfered from OR to PACU with endotracheal intubation and then extubated in PACU.
PROCEDUREExtubation in operating room (OR)
At the end of surgery, patients will be extubated in OR and then transfered from OR to PACU.
Sponsors
Peking University First Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged ≥18 years; 2. Scheduled to undergo elective robot-assisted laparoscopic surgery under general anesthesia; 3. Expected tracheal extubation during daytime working hours (before 4:00 PM).
Exclusion criteria
1. Refuse to participate in the study; 2. Morbid obesity (body mass index ≥35 kg/m²); 3. Preoperatively diagnosed obstructive sleep apnea, or patients with a STOP-Bang score ≥3 in combination with serum bicarbonate (HCO₃-) ≥28 mmol/L; 4. Patients at high risk of difficult airway (anticipated difficult intubation and/or extubation during preoperative assessment); 5. 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; 6. Significant pulmonary function impairment (FEV₁/FVC ratio \< 70%, and total lung capacity \[TLC\] and vital capacity \[VC\] \< 80% of predicted values); 7. 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; 8. Preoperative diagnoses of schizophrenia, epilepsy, Parkinson's disease, or myasthenia gravis; 9. Inability to communicate due to coma, severe dementia, or language impairment; 10. Planned postoperative admission to the intensive care unit; 11. Any other conditions that are deemed for study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operating room (OR) occupancy time | Up to 2 hours after surgery | Time interval from end of surgery to leaving OR for PACU. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of emergence delirium | Up to 3 hours after surgery | Emergence delirium will be assessed with the confusion assessment method for the intensive care unit (CAM-ICU). |
| Incidence of adverse events before leaving PACU | 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. |
| Time interval from end of surgery to modified Aldrete score of ≥9 | 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. |
| Time interval from end of surgery to PACU discharge | Up to 2 hours after surgery | Time interval from end of surgery to PACU discharge. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 30-day all-cause mortality | Up to 30 days after surgery | 30-day all-cause mortality |
| Time interval from end of surgery to extubation | Up to 3 hours after surgery | Time interval from end of surgery to extubation. |
| Total costs during hospitalization | Up to 30 days after surgery. | Total costs during hospitalization |
| Incidence of postoperative complications within 30 days | 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). |
| Turnover time in the operating room | Up to 3 hours after surgery | Time interval between leaving OR of the last patient and entering OR of the next patient. |
| Ready for surgery time in the operating room | Up to 3 hours after surgery | Time interval between end of surgry of the last patient and ready for surgery of the next patient. |
| Quality of recovery on postoperative day 1 | 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. |
| Length of hospital stay (LOS) after surgery | Up to 30 days after surgery | Length of hospital stay (LOS) after surgery. |
Countries
China
Contacts
Primary ContactDong-Xin Wang, MD, PhD
Backup ContactTing Ding, MD
Outcome results
None listed