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Robotic Surgical ProceduresNCT07332806

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

A study testing Extubation in post-anesthesia care unit (PACU) and Extubation in operating room (OR) in people with Robotic Surgical Procedures and Airway Extubation, run by Peking University First Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Extubation in post-anesthesia care unit (PACU) and Extubation in operating room (OR)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
218 participants
Where
1 siteChina
Study dates
24 Jan 2026to 19 Sep 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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);
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Peking University Fist Hospital

    Beijing, Beijing Municipality, 100034

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Extubation in post-anesthesia care unit (PACU), Extubation in operating room (OR)
Keywords
Robotic Surgical Procedures, Airway Extubation, Operating Rooms, Anesthesia Recovery Period, Postoperative Complications
Medical subject headings
Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Extubation in post-anesthesia care unit (PACU)Procedure or surgery

    Also called PACU extubation

    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 or surgery

    Also called OR extubation

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

Study groups in NCT07332806
Study groupRoleWhat they receive
Extubation in post-anesthesia care unit (PACU)ExperimentalAt the end of surgery, patients will be transferred from operating room (OR) to PACU with endotracheal intubation and then extubated in PACU.
Receives: Procedure: Extubation in post-anesthesia care unit (PACU)
Extubation in operating room (OR)Active comparatorAt the end of surgery, patients will be extubated in operating room (OR) and then transfered to PACU.
Receives: Procedure: Extubation in operating room (OR)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Operating room (OR) occupancy time

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

    Measured: Up to 2 hours after surgery

Secondary outcomes (4)
  1. Incidence of emergence delirium

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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Up to 2 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2026
  2. Study start24 Jan 2026
  3. Primary completion19 Aug 2026
  4. Study completion19 Sep 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
218 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07332806
Sponsor's protocol ID
2025R0568
Status last verified
Oct 2026
First submitted
15 Dec 2025
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40351134
  • 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.

    PubMed 29802903
  • 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.

    PubMed 36520073
  • 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.

    PubMed 34762729
  • 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.

    PubMed 34809752
  • 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.

    PubMed 33435881
  • 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.

    PubMed 9709138

Questions about this trial

What is this clinical trial studying?

A study testing Extubation in post-anesthesia care unit (PACU) and Extubation in operating room (OR) in people with Robotic Surgical Procedures and Airway Extubation, run by Peking University First Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Operating room (OR) occupancy time (time frame: Up to 2 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07332806, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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