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

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

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications; Airway Extubation; Robotic Surgical Procedures; Anesthesia Recovery Period; Operating Rooms
• Intervention / Treatment: Procedure: Extubation in post-anesthesia care unit (PACU); Procedure: Extubation in operating room (OR)

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.

• Study Type: Interventional
• Enrollment (Estimated): 218
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dong-Xin Wang, MD, PhD; Phone Number: 01083572784; Email: wangdongxin@hotmail.com
• Study Contact Backup: Name: Ting Ding, MD; Email: athena_d@sina.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100034
      • Recruiting
      • Peking University Fist Hospital
      • Contact: Dong-Xin Wang, MD, PhD; Phone Number: 01083572784; Email: wangdongxin@hotmail.com
      • Contact: Ting Ding, MD; Email: athena_d@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Extubation in post-anesthesia care unit (PACU); At the end of surgery, patients will be transferred from operating room (OR) to PACU with endotracheal intubation and then extubated in PACU.	Procedure: Extubation 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.; Other Names: PACU extubation
Active Comparator: Extubation in operating room (OR); At the end of surgery, patients will be extubated in operating room (OR) and then transfered to PACU.	Procedure: Extubation in operating room (OR); At the end of surgery, patients will be extubated in OR and then transfered from OR to PACU.; Other Names: OR extubation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operating room (OR) occupancy time	Time interval from end of surgery to leaving OR for PACU.	Up to 2 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of emergence delirium	Emergence delirium will be assessed with the confusion assessment method for the intensive care unit (CAM-ICU).	Up to 3 hours after surgery
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.	Up to 3 hours after surgery
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.	Up to 3 hours after surgery
Time interval from end of surgery to PACU discharge	Time interval from end of surgery to PACU discharge.	Up to 2 hours after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time interval from end of surgery to extubation	Time interval from end of surgery to extubation.	Up to 3 hours after surgery
Turnover time in the operating room	Time interval between leaving OR of the last patient and entering OR of the next patient.	Up to 3 hours after surgery
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.	Up to 3 hours after surgery
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.	At 24 hours after surgery
Length of hospital stay (LOS) after surgery	Length of hospital stay (LOS) after surgery.	Up to 30 days after surgery
30-day all-cause mortality	30-day all-cause mortality	Up to 30 days after surgery
Total costs during hospitalization	Total costs during hospitalization	Up to 30 days after surgery.
Incidence of postoperative complications within 30 days	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).	Up to 30 days after surgery

Collaborators and Investigators

• Sponsor: Peking University First Hospital
• Investigators: Principal Investigator: Dong-Xin Wang, MD, PhD, Peking University First Hospital

Publications and helpful links

General Publications

• Koga K, Asai T, Vaughan RS, Latto IP. Respiratory complications associated with tracheal extubation. Timing of tracheal extubation and use of the laryngeal mask during emergence from anaesthesia. Anaesthesia. 1998 Jun;53(6):540-4. doi: 10.1046/j.1365-2044.1998.00397.x.
• Apfelbaum JL, Hagberg CA, Connis RT, Abdelmalak BB, Agarkar M, Dutton RP, Fiadjoe JE, Greif R, Klock PA, Mercier D, Myatra SN, O'Sullivan EP, Rosenblatt WH, Sorbello M, Tung A. 2022 American Society of Anesthesiologists Practice Guidelines for Management of the Difficult Airway. Anesthesiology. 2022 Jan 1;136(1):31-81. doi: 10.1097/ALN.0000000000004002.
• Thilen SR, Weigel WA, Todd MM, Dutton RP, Lien CA, Grant SA, Szokol JW, Eriksson LI, Yaster M, Grant MD, Agarkar M, Marbella AM, Blanck JF, Domino KB. 2023 American Society of Anesthesiologists Practice Guidelines for Monitoring and Antagonism of Neuromuscular Blockade: A Report by the American Society of Anesthesiologists Task Force on Neuromuscular Blockade. Anesthesiology. 2023 Jan 1;138(1):13-41. doi: 10.1097/ALN.0000000000004379.
• Godet T, Wajew C, Fabrizi M, Monet C, Pouzeratte Y, Lapeyre M, Adelou S, Pereira B, Garnier M, Chanques G, Jabaudon M, Futier E, Jaber S, De Jong A. Impact of tracheal extubation location after surgical procedures on peri-operative times: a prospective dual-centre observational study. Anaesthesia. 2025 Aug;80(8):915-926. doi: 10.1111/anae.16620. Epub 2025 May 12.
• Langeron O, Bourgain JL, Francon D, Amour J, Baillard C, Bouroche G, Chollet Rivier M, Lenfant F, Plaud B, Schoettker P, Fletcher D, Velly L, Nouette-Gaulain K. Difficult intubation and extubation in adult anaesthesia. Anaesth Crit Care Pain Med. 2018 Dec;37(6):639-651. doi: 10.1016/j.accpm.2018.03.013. Epub 2018 May 23.
• Banik RK, Honeyfield K, Qureshi S, Reddy SG. Incidence and Mortality Rate of Perioperative Reintubation: Case Series of 196 Patients. AANA J. 2021 Dec;89(6):476-479.
• Chen S, Zhang Y, Che L, Shen L, Huang Y. Risk factors for unplanned reintubation caused by acute airway compromise after general anesthesia: a case-control study. BMC Anesthesiol. 2021 Jan 12;21(1):17. doi: 10.1186/s12871-021-01238-4.

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2026
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: December 30, 2025
• First Posted (Estimated): January 12, 2026

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative Complications; Anesthesia Recovery Period; Robotic Surgical Procedures; Airway Extubation; Operating Rooms
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Investigative Techniques; Therapeutics; Health Care Facilities Workforce and Services; Airway Management; Health Facilities; Hospital Units; Airway Extubation; Operating Rooms
• Other Study ID Numbers: 2025R0568

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No