Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03807297
Other study ID # RajivGCIRC2
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Recruiting NCT05991453 - Trajectories of Recovery After Intravenous Propofol Versus Inhaled VolatilE Anesthesia Trial N/A
Completed NCT05656703 - Anesthesia Depth Increases Delirium Incidence N/A
Recruiting NCT03773588 - Entropy and Surgical Pleth Index Guided Closed Loop Target Controlled Infusion Total Intravenous Anesthesia With Propofol N/A
Active, not recruiting NCT06337877 - Assessment of Sedation Depth in ARDS Patients Undergoing Therapeutic Paralysis
Completed NCT03438734 - Comparison of Low Versus Normal Flow Anesthesia on Cerebral Oxygenation and Bispectral Index in Morbidly Obese Patients N/A
Not yet recruiting NCT06427785 - The Effect of Wavelet Index in Monitoring the Sedation Depth of Remimazolam Besylate
Completed NCT06316622 - Examination of The Relationshıp Between Body Mass Index And The Skin-Epidural Space Distance N/A
Recruiting NCT06323616 - The Effect of Anesthesia Depth Monitoring on Emergence Delirium in Pediatrics N/A
Recruiting NCT03476213 - Manual Versus Targer-controll Infusion in Reduction of Awareness and Dreaming N/A
Recruiting NCT04009018 - Adaptation of Perioperative Satisfaction Scale in Regional Anesthesia and Investigation of Its Psychometric Properties N/A
Suspended NCT03498391 - A Study of Human Multi-Sensory Integration Phase 2
Completed NCT03521414 - Glasgow Coma Scales and General Anesthesia N/A
Completed NCT03134651 - Preoperative Anxiety at Oocyte Retrieval N/A
Active, not recruiting NCT04826146 - Pediatric Validation of CONOX Monitor During Surgery
Recruiting NCT04788732 - Heart Rate Variability to Quantify General Anesthesia Depth
Recruiting NCT05193747 - The Depth of Paediatric Anaesthesia: Observational Trial
Completed NCT04813952 - The Effect of Minimal Flow Sevoflurane Anesthesia N/A
Completed NCT03503357 - ConsCIOUS2 Study of the Isolated Forearm Technique Commands N/A
Not yet recruiting NCT05254704 - Validation of the French Version of the TEX-Q Questionnaire.