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.
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
- Conditions the study is for
- Robotic Surgical Procedures, Airway Extubation, Operating Rooms
- 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
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.
- Conditions
- Robotic Surgical Procedures, Airway Extubation, Operating Rooms, Anesthesia Recovery Period, Postoperative Complications
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Extubation in operating room (OR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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.
- First posted12 Jan 2026
- Study start24 Jan 2026
- Primary completion19 Aug 2026
- Study completion19 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Robotic Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong-Xin Wang, Peking University First Hospital
- Investigators
- Dong-Xin Wang, MD, PhD, Principal investigator, Peking University First Hospital
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 40351134Langeron 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 29802903Thilen 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 36520073Apfelbaum 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 34762729Banik 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 34809752Chen 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 33435881Koga 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
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Site of Tracheal Extubation on Operating Room Efficiency During Robot-assisted Surgery: a Randomized Trial
- ClinicalTrials.gov ID
- NCT07332806
- Acronym / sponsor ID
- 2025R0568
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 24 Jan 2026 (actual)
- Primary completion
- 19 Aug 2026 (actual)
- Study completion
- 19 Sep 2026 (actual)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extubation in post-anesthesia care unit (PACU) | Experimental | Procedure: 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. |
| Extubation in operating room (OR) | Active comparator | Procedure: Extubation in operating room (OR)At the end of surgery, patients will be extubated in operating room (OR) and then transfered to PACU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extubation in post-anesthesia care unit (PACU)Also: PACU extubationAt the end of surgery, patients will be transfered from OR to PACU with endotracheal intubation and then extubated in PACU. | Procedure or surgery | Extubation in post-anesthesia care unit (PACU) |
| Extubation in operating room (OR)Also: OR extubationAt the end of surgery, patients will be extubated in OR and then transfered from OR to PACU. | Procedure or surgery | Extubation in operating room (OR) |
Primary outcome
Operating room (OR) occupancy time
Time frame: Up to 2 hours after surgery
Time interval from end of surgery to leaving OR for PACU.
4 secondary outcomes
Incidence of emergence delirium
Time frame: Up to 3 hours after surgery
Incidence of adverse events before leaving PACU
Time frame: Up to 3 hours after surgery
Time interval from end of surgery to modified Aldrete score of ≥9
Time frame: Up to 3 hours after surgery
Time interval from end of surgery to PACU discharge
Time frame: Up to 2 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Background: PubMed 40351134Godet 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.
- Background: PubMed 29802903Langeron 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.
- Background: PubMed 36520073Thilen 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.
- Background: PubMed 34762729Apfelbaum 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.
- Background: PubMed 34809752Banik 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.
- Background: PubMed 33435881Chen 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.
- Background: PubMed 9709138Koga 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong-Xin Wang, MD, PhD principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
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.