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Comparing of intraoperative opiod consumption when administered by SPI guidance in patient undergoing elective laparoscopic cholecystectomy under general anesthesia with either total intravenous anesthetic agent or inhalational agent - A Prospective Observational Study

Comparison of intraoperative opiod consumption when administered by SPI guidance in patient undergoing elective laparoscopic cholecystectomy under balanced general anesthesia with either TIVA/TCI or inhalational agent - A Prospective Observational Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/02/104710
Enrollment
60
Registered
2026-02-25
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Health Condition 1: K800- Calculus of gallbladder with acutecholecystitis

Interventions

Intervention1: NIL: NIL Intervention2: OPIOD- FENTANYL ADMINISTRATION UNDER SPI GUIDANCE: OPIOD- FENTANYL ADMINISTERED IF SPI IS MORE THAN 60 FOR 3 MTS IN BOTH TIVA/TCI VS INHALATIONAL AGENT

Sponsors

PRINCY.S
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: PATIENT BELONGING ASA 1& 2 PATIENT CONSENTING TO STUDY ELECTIVE LAPAROSCOPIC CHOLECYSTECTOMY

Exclusion criteria

Exclusion criteria: ASA3 OR MORE OPIOD ABUSE CHRONIC PAIN SEVERE PERIPHERAL/CARDIAC AUTONOMIC NEUROPATHY ALLERGIC TO PROPOFOL,FENTANYL,NSAID PREGNANT & LACTATING MOTHER SYSTEMIC INFECTION PSYCHIATRIC ILLNESS EMERGENCY SURGERY

Design outcomes

Primary

MeasureTime frame
Comparison of intraoperative opioid consumption when administered under SPI guidance in patients undergoing elective laparoscopic cholecystectomy via TIVA/TCI or Inhalational agentTimepoint: BASELINE 2MINUTES AFTER INDUCING ANESTHESIA 2minutes After Intubation 2minutes After Incision 2 minutes AFTER INSUFFLATION 2 minutes AFTER DEFLATION 2 minutes BEFORE EXTUBATION—

Secondary

MeasureTime frame
To asses pain scores post operatively in both TIVA/TCI & Inhalational agent. To evaluate whether Pre-extubation SPI scores correlate with postoperative pain scores. Timepoint: NRS Scores assessed upto 24 hr post procedure on various time interval from shifting out from PACU to 6hrs, 12 hrs& 24 hrs—

Countries

India

Contacts

Public ContactDR SUDEEP

SAKRA WORLD HOSPITAL, BANGALORE

Duspee77@yahoo.co.in9148451545

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026