Peking University Fist Hospital
Beijing, Beijing Municipality, 100034, China
Location status: Recruiting
Location contact
Dong-Xin Wang, MD, PhD
CONTACT
Ting Ding, MD
CONTACT
NCT Number: NCT07332806
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100034, China
Location status: Recruiting
Dong-Xin Wang, MD, PhD
CONTACT
Ting Ding, MD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
At the end of surgery, patients will be extubated in OR and then transfered from OR to PACU.
Other names: OR extubation
Time frame: Up to 2 hours after surgery
Time interval from end of surgery to leaving OR for PACU.
Time frame: Up to 3 hours after surgery
Emergence delirium will be assessed with the confusion assessment method for the intensive care unit (CAM-ICU).
Time frame: Up to 3 hours after surgery
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.
Time frame: Up to 3 hours after surgery
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.
Time frame: Up to 2 hours after surgery
Time interval from end of surgery to PACU discharge.
Time frame: Up to 3 hours after surgery
Time interval from end of surgery to extubation.
Time frame: Up to 3 hours after surgery
Time interval between leaving OR of the last patient and entering OR of the next patient.
Time frame: Up to 3 hours after surgery
Time interval between end of surgry of the last patient and ready for surgery of the next patient.
Time frame: At 24 hours after surgery
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.
Time frame: Up to 30 days after surgery
Length of hospital stay (LOS) after surgery.
Time frame: Up to 30 days after surgery
30-day all-cause mortality
Time frame: Up to 30 days after surgery
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).
Time frame: Up to 30 days after surgery.
Total costs during hospitalization
Contact information is provided by the study sponsor or research team.
Dong-Xin Wang, MD, PhD
CONTACT
Ting Ding, MD
CONTACT
Peking University First Hospital
Other
Impact of Site of Tracheal Extubation on Operating Room Efficiency During Robot-assisted Surgery: a Randomized Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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