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Modified Deep Extubation vs. Standard Awake Extubation

ConditionExtubation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorSamuel Lunenfeld Research Institute, Mount Sinai Hospital

About this trial

The proposed study is to compare a modified DE technique, which is regularly used for low-risk patients by staff anesthesiologists at our institution, to a standard awake extubation. This modified deep extubation (mDE) occurs while the patient is still anaesthetized but at a lower dose of anaesthetic gas than previously described, and balanced with long acting opioids to attenuate the airway reaction. As previously stated, the literature shows that the risks of DE are equivalent to those of regular AE practice. Our hypothesis is that mDE will shorten the time from the end of the surgery (completion of last stitch) to the moment the patient is ready to leave the OR by at least 5 minutes when compared to standard AE practice.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ASA I-III

laparoscopic surgery under general anesthesia

Disqualifiers

Documented difficult airway during intubation or developed intraoperatively.

Full stomach

Pregnant women

Emergency surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • modified deep extubation (mDE)

    Procedure/Surgery

    The proposed study is to compare a modified DE technique, which is regularly used for low-risk patients by staff anesthesiologists at our institution, to a standard awake extubation.

  • standard awake extubation

    Procedure/Surgery

    awake extubation (AE) is still considered the standard practice.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: modified deep extubationExperimental treatment 1 intervention
Group B: standard awake extubationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Time from the end of the surgery to leaving the OR

Time from the end of the surgery (completion of the last stitch) to the time the patient is ready to safely leave the OR (defined as the moment when the patient breaths spontaneously with SpO2 \> 97 % while receiving oxygen by a facial mask at 6-8 L/min, with normal chest wall movement, no airway obstruction and the presence of ETCO2 waveform).

Time frame
Time from the end of the surgery (completion of the last stitch) to the time the patient is ready to safely leave the OR

Secondary outcomes

1

Time from the end of the surgery to extubation

Time from the end of the surgery (completion of the last stitch) to the moment of extubation (representing the period of extubation that is part of the surgical time).

Time frame
Time from the end of the surgery (completion of the last stitch) to the moment of extubation
2

Time from the end of the surgery to discharge from PACU

Time from the end of the surgery to the moment the patient is ready to be discharged from PACU (Aldrete score greater or equal than 9) as per institutional protocol

Time frame
Time from the end of the surgery to the moment the patient is ready to be discharged from PACU
3

oral airway

Incidence of usage of oral airway.

Time frame
from intubation to extubation during the surgery/procedure
4

jaw-thrust maneuver

Incidence of performance of jaw-thrust maneuver and time of usage.

Time frame
from intubation to extubation during the surgery/procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Lead sponsor

Source ClinicalTrials.gov
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