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

NCT07332806 | Recruiting DMC

• 1 other identifier: 2025R0568
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 1

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.

Conditions

Robotic Surgical Procedures; Airway Extubation; Operating Rooms; Anesthesia Recovery Period; Postoperative Complications

Keywords

Robotic Surgical Procedures; Airway Extubation; Operating Rooms; Anesthesia Recovery Period; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• Operating room (OR) occupancy time

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

  Up to 2 hours after surgery

Secondary Outcomes (4)

• Incidence of emergence delirium

  Up to 3 hours after surgery

• Incidence of adverse events before leaving PACU

  Up to 3 hours after surgery

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

  Up to 3 hours after surgery

• Time interval from end of surgery to PACU discharge

  Up to 2 hours after surgery

Other Outcomes (8)

• Time interval from end of surgery to extubation

  Up to 3 hours after surgery

• Turnover time in the operating room

  Up to 3 hours after surgery

• Ready for surgery time in the operating room

  Up to 3 hours after surgery

Study Arms (2)

Extubation in post-anesthesia care unit (PACU)

EXPERIMENTAL

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)

Extubation in operating room (OR)

ACTIVE COMPARATOR

At the end of surgery, patients will be extubated in operating room (OR) and then transfered to PACU.

Procedure: Extubation in operating room (OR)

Interventions

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.

Also known as: PACU extubation

Extubation in post-anesthesia care unit (PACU)

Extubation in operating room (OR) PROCEDURE

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

Also known as: OR extubation

Extubation in operating room (OR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University Fist Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Related Publications (7)

• 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.

  PMID: 40351134 BACKGROUND

• 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.

  PMID: 29802903 BACKGROUND

• 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.

  PMID: 36520073 BACKGROUND

• 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.

  PMID: 34762729 BACKGROUND

• 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.

  PMID: 34809752 BACKGROUND

• 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.

  PMID: 33435881 BACKGROUND

• 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.

  PMID: 9709138 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Interventions

Airway Extubation; Operating Rooms

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Investigative Techniques; Hospital Units; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong-Xin Wang, MD, PhD

CONTACT

01083572784; wangdongxin@hotmail.com

Ting Ding, MD

CONTACT

athena_d@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Professor

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: January 12, 2026
• Study Start: January 12, 2026
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)