TIVA vs Inhalational Mode of Anaesthesia
Primary Purpose
Anesthesia Awareness
Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Injection dexmedetomidine
Injection, Propofol, 10 Mg
sevoflurane
nitrous oxide
Sponsored by
About this trial
This is an interventional other trial for Anesthesia Awareness focused on measuring total intravenous anesthesia
Eligibility Criteria
Inclusion Criteria:
- Age group: 30-65 yrs
- ASA status: 1-3
- Use of endotracheal tube for securing the airway
Exclusion Criteria:
- CKD, CLD patients
- Cardiac dysfunction
- Psychotic and neurotic disorders
- Drug addiction
- BMI > 30
- Use of supraglottic device
- Use of any nerve blocks
Sites / Locations
- Rajiv Gandhi Cancer Institute and Research Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
TIVA - total intravenous anaesthesia
Inhalational anaesthesia
Arm Description
only intravenous type of anaesthesia using Injection propofol, 10 mg and Injection dexmedetomidine drug infusion will be infused for maintenance of anaesthesia
In this group, both nitrous oxide and sevoflurane will be given for maintenance of anaesthesia
Outcomes
Primary Outcome Measures
total intravenous anesthesia
Intraoperative Bispectral index maintenance between 40-60
Secondary Outcome Measures
Cost - effectiveness
cost of drugs consumed per patient in both groups
Full Information
NCT ID
NCT03807297
First Posted
January 5, 2019
Last Updated
February 16, 2020
Sponsor
Rajiv Gandhi Cancer Institute & Research Center, India
1. Study Identification
Unique Protocol Identification Number
NCT03807297
Brief Title
TIVA vs Inhalational Mode of Anaesthesia
Official Title
Comparative Study Between TIVA Vs Inhalational Modes of Anaesthesia in Patients Undergoing Modified Radical Mastectomy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rajiv Gandhi Cancer Institute & Research Center, India
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Sevoflurane based inhalational anaesthesia is the preferred mode of anesthesia for small duration cases. But in recent times, concept of rapid discharge, day care procedures, and green environment has created the need of new modalities of anaesthesia for such cases. Considering such factor, investigators have planned using TIVA i.e. total intravenous anaesthesia with Inj. Propofol and Inj. Dexmedetomidine infusions for maintenance of anesthesia in Modified Radical Mastectomy (MRM). By comparing the two modalities of anaesthesia i.e. TIVA vs Inhalational investigators are trying to find out whether TIVA is feasible, cost effective and comparable to inhalational anaesthesia in terms of intraoperative hemodynamic stability, pain, intraoperative awareness and recovery profile. This comparison and analysis will help to determine if TIVA can be used as the sole mode of anaesthesia during MRM as it will initiate early discharge of patient and will contribute to the Green OT concept.
Detailed Description
Aim: To compare TIVA Vs Inhalational mode of anaesthesia in patients undergoing Modified Radical Mastectomy
Objective:
Feasibility of TIVA in Modified Radical Mastectomy
Cost - effectiveness of TIVA Vs Inhalational anesthesia
Effectiveness of TIVA as compared to Inhalational Anaesthesia by comparing intraoperative hemodynamic parameters and recovery profile.
Study design: It will be a prospective randomized controlled interventional type of study.
Sample size: Total 100 patients will be recruited for two groups i.e. 50 each in -TIVA (T) and Inhalational (I) group. Groups will be allocated as per chit system to remove the bias.
In group T: (TIVA): Inj. Dexmedetomidine will be started at induction @1mcg/kg over 10 min followed by 0.2 to 0.7 mcg/kg/hr along with propofol @ 75mcg/kg/min (25-100 mcg/kg/min) for maintenance of anaesthesia.
In group I: (inhalational): both nitrous oxide (in ratio of 50:50 with oxygen) and sevoflurane will be started at induction.
In both groups drugs and gases (respective to groups) will be titrated to maintain a bispectral index value between 40-60. Anaesthetic drugs will be stopped at last skin suture. Soon after reversal- recovery profile, modified Aldrete score will be recorded along with time taken to first eye opening and attainment of BIS value of >90. At the end of case amount of each agents consumed will be recorded - i.e. nitrous oxide, sevoflurane, propofol, dexmedetomodine- for cost analysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia Awareness
Keywords
total intravenous anesthesia
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
two groups - one for Total Intravenous Anaesthesia mode and other for Inhalational mode of anaesthesia
Masking
ParticipantInvestigator
Masking Description
participants will be alloted in two groups as per chit system and won't be aware of type of anaesthesia, investigator won't be aware of type of anaesthesia and will record the data.
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TIVA - total intravenous anaesthesia
Arm Type
Other
Arm Description
only intravenous type of anaesthesia using Injection propofol, 10 mg and Injection dexmedetomidine drug infusion will be infused for maintenance of anaesthesia
Arm Title
Inhalational anaesthesia
Arm Type
Other
Arm Description
In this group, both nitrous oxide and sevoflurane will be given for maintenance of anaesthesia
Intervention Type
Drug
Intervention Name(s)
Injection dexmedetomidine
Other Intervention Name(s)
dexmed
Intervention Description
alpha 2 a agonist used for sedation, analgesia
Intervention Type
Drug
Intervention Name(s)
Injection, Propofol, 10 Mg
Other Intervention Name(s)
propofol spiva
Intervention Description
non barbiturate type of intravenous anaesthetic drug
Intervention Type
Other
Intervention Name(s)
sevoflurane
Intervention Description
inhalational anaesthetic agent
Intervention Type
Other
Intervention Name(s)
nitrous oxide
Intervention Description
inhalational anaesthetic agent
Primary Outcome Measure Information:
Title
total intravenous anesthesia
Description
Intraoperative Bispectral index maintenance between 40-60
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
Cost - effectiveness
Description
cost of drugs consumed per patient in both groups
Time Frame
3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age group: 30-65 yrs
ASA status: 1-3
Use of endotracheal tube for securing the airway
Exclusion Criteria:
CKD, CLD patients
Cardiac dysfunction
Psychotic and neurotic disorders
Drug addiction
BMI > 30
Use of supraglottic device
Use of any nerve blocks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
NITESH GOEL, MBBS,DA,DNB
Organizational Affiliation
Rajiv Gandhi Cancer Institute And Research Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rajiv Gandhi Cancer Institute and Research Centre
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110085
Country
India
12. IPD Sharing Statement
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TIVA vs Inhalational Mode of Anaesthesia
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