TIVA vs Inhalational Mode of Anaesthesia

Anesthesia Awareness Clinical Trial

Official title:

Comparative Study Between TIVA Vs Inhalational Modes of Anaesthesia in Patients Undergoing Modified Radical Mastectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03807297
• Other study ID #: RajivGCIRC2
• Status: Completed
• Phase: Phase 2
• Start date: January 10, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: February 2020
• Source: Rajiv Gandhi Cancer Institute & Research Center, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia Awareness
• Intraoperative Awareness

Intervention

Drug:
• Injection dexmedetomidine
alpha 2 a agonist used for sedation, analgesia
• Injection, Propofol, 10 Mg
non barbiturate type of intravenous anaesthetic drug

Other:
• sevoflurane
inhalational anaesthetic agent
• nitrous oxide
inhalational anaesthetic agent

Locations

Country	Name	City	State
India	Rajiv Gandhi Cancer Institute and Research Centre	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Rajiv Gandhi Cancer Institute & Research Center, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total intravenous anesthesia	Intraoperative Bispectral index maintenance between 40-60	3 hours
Secondary	Cost - effectiveness	cost of drugs consumed per patient in both groups	3 hours