Anaesthesia Requirements for Ventilation With Endotracheal Tube Versus ProSeal Laryngeal Mask Airway During Automated Feedback-Loop Controlled Total Intravenous Anaesthesia in Patients Undergoing Laparoscopic Cholecystectomy: A Randomised Controlled Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Endotracheal tube (ETT) is the gold standard conduit for providing controlled ventilation during general anaesthesia (GA). however, the supra-glottic airway (SGA) devices in particular the laryngeal mask airway (LMA) and its variants have become a reliable alternative to ETT for carrying out controlled ventilation. Of the several variants of LMA available today, the proseal LMA (PLMA) is preferred for controlled ventilation. The various advantages of LMA includes, a lower incidence of postoperative sore throat and superior haemodynamic profile during surgery. However, one aspect of providing anaesthesia with LMA compared to ETT is the ability of LMA to maintain equivalent depth of anaesthesia with lower anaesthetic requirement, is quiet intriguing and evidence to this regard is very limited. By measuring the anaesthesia requirement using a robust computerised delivery system such as the closed loop anaesthesia delivery system (CLADS) we can establish for sure the anaesthesia required for maintaining intraoperative mechanical ventilation with the use of these two (ETT and PLMA) airway management devices. This randomised controlled study aims to calculate the anaesthesia requirement as determined by the total amount of propofol consumed for maintaining anaesthesia with ETT versus PLMA

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• ASA physical status I/II

• Undergoing elective laparoscopic cholecystectomy

Locations
Other Locations
India
Sir Ganga Ram Hospital
RECRUITING
New Delhi
Contact Information
Primary
Nitin Sethi, DNB
nitinsethi77@yahoo.co.in
00919717494498
Backup
Amitabh Dutta, MD
duttaamiatbh@yahoo.co.in
+911142252523
Time Frame
Start Date: 2019-03-04
Estimated Completion Date: 2025-12
Participants
Target number of participants: 160
Treatments
Active_comparator: ETT Group
Anesthesia will be induced with fentanyl-citrate (3µg/kg) and propofol (dose determined by automated system based on continuous BIS feedback from the patients). Atracurium besylate 0.5-mg/kg will be given to facilitate placement of airway device. Propofol administration rate will be controlled by a feedback loop facilitated by BIS monitoring using the closed-loop anaesthesia delivery system (CLADS). A BIS value of 50 will be used as the target point for induction and maintenance of GA.~Intraoperative ventilation will be instituted through a polyvinyl chloride (PVC) ETT (Portex, Smiths Medical ASD, Inc, Minneapolis, USA). The size of the tube will be standardized for the male (7.5 mm ID) and the female (6.5 MM ID).
Active_comparator: PLMA Group
Anesthesia will be induced with fentanyl-citrate (3µg/kg) and propofol (dose determined by automated system based on continuous BIS feedback from the patients). Atracurium besylate 0.5-mg/kg will be given to facilitate placement of airway device. Propofol administration rate will be controlled by a feedback loop facilitated by BIS monitoring using the closed-loop anaesthesia delivery system (CLADS). A BIS value of 50 will be used as the target point for induction and maintenance of GA. intraoperative ventilation will be maintained with PLMA (Telefex Medical, Westmeath Ireland) whose size would be selected based on body weight. In patients weighing 30-50 kg PLMA # 3.0, 50-70 kg PLMA # 4.0, and 50-100 kg PLMA # 5.0 will be inserted.
Sponsors
Leads: Sir Ganga Ram Hospital

This content was sourced from clinicaltrials.gov

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