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

NCT ID: NCT07332806

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

218 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-12

Study Completion Date

2026-04-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Extubation in post-anesthesia care unit (PACU)

Intervention Type PROCEDURE

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)

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

Group Type ACTIVE_COMPARATOR

Extubation in operating room (OR)

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Extubation in operating room (OR)

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

Intervention Type PROCEDURE

Other Intervention Names

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PACU extubation OR extubation

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University First Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dong-Xin Wang

Chief Physician, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dong-Xin Wang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

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Peking University Fist Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dong-Xin Wang, MD, PhD

Role: CONTACT

01083572784

Ting Ding, MD

Role: CONTACT

Facility Contacts

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Dong-Xin Wang, MD, PhD

Role: primary

01083572784

Ting Ding, MD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 40351134 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29802903 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36520073 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34762729 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34809752 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33435881 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9709138 (View on PubMed)

Other Identifiers

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2025R0568

Identifier Type: -

Identifier Source: org_study_id

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