To compare blood pressure changes between 2 novel anesthesia delivery modalities in adult patients undergoing elective laparoscopic surgery

Comparison of mean blood pressure variability in conox-guided total intravenous anaesthesia and closed-loop anaesthesia delivery system in adult patients undergoing elective laparoscopic surgery: a randomized control trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/098344

Enrollment

104

Registered

2025-12-03

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: GROUP A (CONOX guided TIVA): Anaesthesia will be delivered using Conventional TIVA under the guidance of CONOX monitoring and intraoperative hemodynamics and patient responses will be m

Eligibility

Inclusion criteria

Inclusion criteria: a. Adult patients ( more than 18 years) b. Undergoing elective laparoscopic surgery requiring general anesthesia for more than 120 minutes c. ASA (American society of anesthesiologists) physical status 1-3

Exclusion criteria

Exclusion criteria: Known allergies to propofol, fentanyl, or other anesthetics b. Significant cardiovascular, respiratory, neurological disorders, or uncontrolled endocrine diseases c. Pregnant or lactating women

Design outcomes

Primary

Measure	Time frame
To evaluate intraoperative hemodynamic stability, specifically mean arterial pressure (MAP), during elective laparoscopic surgeries, with a target MAP variation of 25% from baseline in CONOX-guided Total Intravenous Anaesthesia (TIVA) and BIS-monitored Closed-Loop Anesthesia Delivery Systems (CLADS).Timepoint: Throughout duration of intraoperative period at 5 minutes intervals from induction to extubation, study to be conducted over a period of 1 year from date of approval.	—

Measure

Time frame

To evaluate intraoperative hemodynamic stability, specifically mean arterial pressure (MAP), during elective laparoscopic surgeries, with a target MAP variation of 25% from baseline in CONOX-guided Total Intravenous Anaesthesia (TIVA) and BIS-monitored Closed-Loop Anesthesia Delivery Systems (CLADS).Timepoint: Throughout duration of intraoperative period at 5 minutes intervals from induction to extubation, study to be conducted over a period of 1 year from date of approval.

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Secondary

Measure	Time frame
1. Heart Rate Variability: To evaluate intraoperative heart rate variability ( 25% from baseline) every 5 minutes as an indicator of autonomic stability & anesthetic effects. 2. Time to Extubation: To compare the time to extubation, reflecting the recovery profile & anesthesia depth. 3. Modified Aldrete Score (Recovery Profile): To assess postoperative recovery using the Modified Aldrete Score, evaluating consciousness, motor function, & vital signs. 4. Incidence of Postoperative Nausea & Vomiting (PONV): To compare the incidence of PONV between the two anesthetic techniques. 5. Overall Propofol & Fentanyl Consumption: To assess the total consumption of propofol & fentanyl, comparing drug usage between CONOX-guided TIVA & BIS-monitored CLADS. Timepoint: Heart rate variability at every 5 minutes interval intraoperatively & time to extubation to be measured at the end of surgery to extubation of the trachea. Modified Aldrete score Drug consumption PONV occurence in immediate post operative & 1 hour from end of surgery. The study will be conducted over period of 1 year from enrollment date.	—

Measure

Time frame

1. Heart Rate Variability: To evaluate intraoperative heart rate variability ( 25% from baseline) every 5 minutes as an indicator of autonomic stability & anesthetic effects. 2. Time to Extubation: To compare the time to extubation, reflecting the recovery profile & anesthesia depth. 3. Modified Aldrete Score (Recovery Profile): To assess postoperative recovery using the Modified Aldrete Score, evaluating consciousness, motor function, & vital signs. 4. Incidence of Postoperative Nausea & Vomiting (PONV): To compare the incidence of PONV between the two anesthetic techniques. 5. Overall Propofol & Fentanyl Consumption: To assess the total consumption of propofol & fentanyl, comparing drug usage between CONOX-guided TIVA & BIS-monitored CLADS. Timepoint: Heart rate variability at every 5 minutes interval intraoperatively & time to extubation to be measured at the end of surgery to extubation of the trachea. Modified Aldrete score Drug consumption PONV occurence in immediate post operative & 1 hour from end of surgery. The study will be conducted over period of 1 year from enrollment date.

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Countries

India

Contacts

Public ContactDr Freddie Flavian Cruz S

All India Institute of Medical Sciences Jodhpur

geetamanoj007@yahoo.co.in9414084584

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026