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Comparison of Anaesthesia Requirement for Ventilation With Endotracheal Tube Versus Proseal Laryngeal Mask Airway

Primary Purpose

Cholelithiases, Cholecystolithiasis

Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Endotracheal tube (ETT)
ProSeal Laryngeal Mask Airway (PLMA)
Sponsored by
Sir Ganga Ram Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cholelithiases

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. ASA physical status I/II
  2. Undergoing elective laparoscopic cholecystectomy

Exclusion Criteria:

  1. Anticipated difficult airway
  2. Body mass index > 30-kg/m2
  3. Uncompensated cardiovascular disease (e.g. uncontrolled hypertension, atrio-ventricular block, sinus bradycardia, congenital heart disease, reduced LV compliance, diastolic dysfunction)
  4. Hepato-renal insufficiency
  5. Uncontrolled endocrinology disease (e.g. diabetes mellitus, hypothyroidism)
  6. Known allergy/hypersensitivity to the study drug (propofol)
  7. Drug dependence/substance abuse/psychiatric illness
  8. Requirement of postoperative ventilation
  9. Refusal to informed consent

Sites / Locations

  • Sir Ganga Ram HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ETT Group

PLMA Group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Change in Propofol usage in milligrams
Comparison of quantitative difference in propofol requirement between the two groups

Secondary Outcome Measures

Anaesthesia depth consistency using BIS scores
Determined by the percentage of the total anaesthesia time in which the BIS scores remain within a score of 10% of the target BIS (i.e. BIS-50) in both the study arms.
Evaluation of propofol anaesthesia delivery system
Determined by using Varvel criteria parameters; median performance error (MDP), median absolute performance error (MDAPE), wobble and global score in both the study arms
Change in Intra-operative heart Rate (beats per minute)
Comparison of intra-operative heart rate between both the arms will be done
Change in Intra-operative systolic , diastolic, and mean (mmHg)
Comparison of intra-operative blood pressure- systolic, diastolic, and mean between both the arms will be done
Early Recovery from anesthesia
Time taken by the patient to open his/her eyes after discontinuation of anaesthesia will be noted
Post operative sedation
Will be assessed using Modified Observer's assessment of alertness/sedation scale (MOAA/S)
Incidence of postoperative sore throat
Comparison of post operative sore throat occurrence between the two groups

Full Information

First Posted
January 19, 2019
Last Updated
April 24, 2023
Sponsor
Sir Ganga Ram Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03812718
Brief Title
Comparison of Anaesthesia Requirement for Ventilation With Endotracheal Tube Versus Proseal Laryngeal Mask Airway
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 4, 2019 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sir Ganga Ram Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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
Detailed Description
Endotracheal tube (ETT) is the gold standard conduit for providing controlled ventilation during general anesthesia (GA). However, since the introduction of classic laryngeal mask airway (LMA) in the 1980's and serial evolution of supra-glottic airway devices (SGA) thereafter, LMAs have become a reliable alternative to ETT for carrying out controlled ventilation. Interestingly, of the additional advantages that the LMA proffers, including, a lower incidence of postoperative sore throat (POST) and superior hemodyamic profile during surgery; its ability to maintain equivalent depth of anesthesia (in comparison to when ETT-GA) with lower anesthetic requirement, is intriguing. A handful of studies have demonstrated that the end-tidal isoflurane concentration required for maintenance of GA is 0.2 -0.53% greater with use of ETT as compared to LMA. However, the evidence generated by these studies remains unsubstantiated because in them, anaesthetic gas concentration was titrated to patient's clinical profile like heart rate and blood pressure without the backing of specific protocol for maintaining depth-of-anaesthesia. Therefore, for credible evidence, assessment of quantitative anesthetic requirement for achieving and sustaining a steady anesthesia depth with either LMA or ETT warrants confirmation with the use of an objective depth-of-anesthesia monitor, such as, bispectral index (BIS). Closed loop anaesthesia delivery system (CLADS) is an indigenously developed patented (502/DEL/2003) computer-controlled and BIS-guided automated anesthesia delivery system. CLADS, which runs on a control algorithm based on the relationship between diverse rates of propofol infusion and the processed EEG variable; delivers propofol infusion at a rate which is continuously adjusted by patient's state of depth of anesthesia as per BIS monitoring input. This automated system maintains anaesthesia depth with high accuracy and objectively determines propofol delivery quantitatively. Of the several variants of SGA available today, the ProSeal laryngeal mask airway (PLMA) 9 is preferred for controlled ventilation for its unique design that serves dual function of a ventilation tube and an oropharyngeal drainage tube for excluding gastric contents from getting aspirated through the peri-laryngeal cuff seal. Given that CLADS can help us to accurately quantify anaesthesia, we hypothesize that there is no difference in anesthesia requirement for GA maintained through an ETT or a PLMA. This randomized controlled study aims to compare: anaesthesia requirement as determined by total propofol consumption (primary objective); intraoperative hemodynamic profile and incidence of POST (secondary objectives) in patients undergoing laparoscopic surgery with controlled ventilation via ETT or PLMA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholelithiases, Cholecystolithiasis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
160-patients will be randomly divided into one of the two groups: Group-I (ETT group, n= 80) ETT will be used as the airway device for maintaining ventilation Group-2 (PLMA group, n= 80) PLMA will be used as the airway device for maintaining ventilation
Masking
ParticipantOutcomes Assessor
Masking Description
The attending anaesthesiologist will not be blinded to the technique utilized to administer GA. An independent assessor unaware of the technique utilized for administering GA will analyse the intraoperative data and conduct the postoperative follow up
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ETT Group
Arm Type
Active Comparator
Arm Description
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).
Arm Title
PLMA Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Endotracheal tube (ETT)
Intervention Description
After induction of anaesthesia patient will be intubated with polyvinyl chloride (PVC) ETT for maintaining intraoperative ventilation. Anaesthesia will be maintained with propofol and the 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.
Intervention Type
Device
Intervention Name(s)
ProSeal Laryngeal Mask Airway (PLMA)
Intervention Description
After induction of anaesthesia ProSeal Laryngeal Mask Airway (PLMA) will be inserted for maintaining intraoperative ventilation. Anaesthesia will be maintained with propofol and the 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.
Primary Outcome Measure Information:
Title
Change in Propofol usage in milligrams
Description
Comparison of quantitative difference in propofol requirement between the two groups
Time Frame
From beginning of anaesthesia (0-hours, baseline) till 4 hours intraoperatively
Secondary Outcome Measure Information:
Title
Anaesthesia depth consistency using BIS scores
Description
Determined by the percentage of the total anaesthesia time in which the BIS scores remain within a score of 10% of the target BIS (i.e. BIS-50) in both the study arms.
Time Frame
From beginning of anaesthesia (0-hours, baseline) till 3 hours intraoperatively
Title
Evaluation of propofol anaesthesia delivery system
Description
Determined by using Varvel criteria parameters; median performance error (MDP), median absolute performance error (MDAPE), wobble and global score in both the study arms
Time Frame
From beginning of anaesthesia (0-hours, baseline) till 3 hours intraoperatively
Title
Change in Intra-operative heart Rate (beats per minute)
Description
Comparison of intra-operative heart rate between both the arms will be done
Time Frame
From beginning of anaesthesia (0-hours, baseline) till 3 hours intraoperatively
Title
Change in Intra-operative systolic , diastolic, and mean (mmHg)
Description
Comparison of intra-operative blood pressure- systolic, diastolic, and mean between both the arms will be done
Time Frame
From beginning of anaesthesia (0-hours, baseline) till 10 hours intraoperatively
Title
Early Recovery from anesthesia
Description
Time taken by the patient to open his/her eyes after discontinuation of anaesthesia will be noted
Time Frame
From end of anaesthesia till 20-minutes postoperatively
Title
Post operative sedation
Description
Will be assessed using Modified Observer's assessment of alertness/sedation scale (MOAA/S)
Time Frame
From the end of anaesthesia till 24-hours, postoperatively
Title
Incidence of postoperative sore throat
Description
Comparison of post operative sore throat occurrence between the two groups
Time Frame
From the end of anaesthesia till 24-hours, postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA physical status I/II Undergoing elective laparoscopic cholecystectomy Exclusion Criteria: Anticipated difficult airway Body mass index > 30-kg/m2 Uncompensated cardiovascular disease (e.g. uncontrolled hypertension, atrio-ventricular block, sinus bradycardia, congenital heart disease, reduced LV compliance, diastolic dysfunction) Hepato-renal insufficiency Uncontrolled endocrinology disease (e.g. diabetes mellitus, hypothyroidism) Known allergy/hypersensitivity to the study drug (propofol) Drug dependence/substance abuse/psychiatric illness Requirement of postoperative ventilation Refusal to informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nitin Sethi, DNB
Phone
00919717494498
Email
nitinsethi77@yahoo.co.in
First Name & Middle Initial & Last Name or Official Title & Degree
Amitabh Dutta, MD
Phone
+911142252523
Email
duttaamiatbh@yahoo.co.in
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nitin Sethi, DNB
Organizational Affiliation
Sir Ganga Ram Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amitabh Dutta, MD
Organizational Affiliation
Sir Ganga Ram Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jayashree Sood, MD, FFRCA
Organizational Affiliation
Sir Ganga Ram Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Sir Ganga Ram Hospital
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110060
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nitin Sethi, DNB
Phone
+911142252523
Email
nitinsethi77@yahoo.co.in
First Name & Middle Initial & Last Name & Degree
Amitabh Dutta, MD
Phone
+911142252523
Email
duttaamiatbh@yahoo.co.in
First Name & Middle Initial & Last Name & Degree
Nitin Sethi, DNB
First Name & Middle Initial & Last Name & Degree
Amitabh Dutta, MD
First Name & Middle Initial & Last Name & Degree
Goverdhan D Puri, MD,PhD
First Name & Middle Initial & Last Name & Degree
Jayashree Sood, MD,FFRCA
First Name & Middle Initial & Last Name & Degree
Bhuwan C Panday, MD
First Name & Middle Initial & Last Name & Degree
Prabhat K Choudhary, MD
First Name & Middle Initial & Last Name & Degree
Manish Gupta, MD
First Name & Middle Initial & Last Name & Degree
Savitar Malhotra, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Anaesthesia Requirement for Ventilation With Endotracheal Tube Versus Proseal Laryngeal Mask Airway

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