Assessing pain relief after the operation after administering the pain killer injection during operation according to measurement done (SPI) using special monitor.

To Determine cut off value of Surgical Pleth Index during general Anaesthesia for adequate postoperative analgesia; prospective randomised, double blind study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/02/012150

Enrollment

Registered

2018-02-26

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Patient undergoing Lumbar Laminectomy and Discectomy surgery

Interventions

Intervention1: SPI30: Boluses of fentanyl during surgery to maintain SPI value up to 30 Control Intervention1: SPI40: Boluses of fentanyl during surgery to maintain SPI value up to 40 Control Interven

Eligibility

Inclusion criteria

Inclusion criteria: 1)Patients undergoing elective lumbar spine surgeries 2)ASA I and ASA II patients 3)patients who have given written consent to participate

Exclusion criteria

Exclusion criteria: 1) patient refusal 2) autonomic neuropathy 3) patient with cardiac arrhythmias 4) presence of a pacemaker 5) medication with anticholinergic drugs, ketamine or clonidine, Beta-blockers

Design outcomes

Primary

Measure	Time frame
Pain score in first 60 minutes of postoperative period Timepoint: Every 5 minutes up to first 60 minutes of postoperative period	—

Secondary

Measure	Time frame
1. Pain score from 1 -24 hour period post-opertively 2.Time for arousal after general anaesthesia with different SPI cut offs 3. Side effect (PONV, pruritus, respiratory depression) up to 24 hours of postopertive periodTimepoint: Up to 24 Hours after surgery	—

Countries

India

Contacts

Public ContactSameer Desai

SDM college of medical sciences and hospital

sameeranaes@gmail.com0836-2477755

Outcome results

None listed

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