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comparison of patient conscious level monitoring during spine surgery with bi-spectral index monitor or patient state index monitor

Comparative efficacy of intra operative patient state index vs bi-spectral index assessment for induction, maintenance and emergence from anesthesia in patients undergoing elective spine surgery under general anaesthesia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/12/038503
Enrollment
80
Registered
2021-12-08
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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: Patient state index monitor: Patients state index monitoring will be done in patient undergoing spine surgery during intraoperative period. Duration: 2-4 hours Control Intervention1: Bi

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients 18- 70 years of age. ASA grade

Exclusion criteria

Exclusion criteria: 1. Use of regional/ neuraxial blocks for intraoperative analgesia. 2. Neurological or psychiatric disorders. 3. Patient on anticonvulsant or other centrally active medications. 4. Clinically significant cardiovascular, respiratory, hepatic, renal, or metabolic disease. 5. Alcohol or drug abuse

Design outcomes

Primary

MeasureTime frame
Comparison of two groups in terms of time of emergence from general anesthesiaTimepoint: After completion of surgery—

Secondary

MeasureTime frame
Comparison of two groups in terms of total intraoperative consumption of anesthetic agentTimepoint: During the entire intra operative period;Incidence of adverse events like incidence of recall, delayed emergence, episodes of hypotension/hypertension and tachycardia/bradycardiaTimepoint: Intraoperative period and up to 1 hour post operative period—

Countries

India

Contacts

Public ContactDeepak Singla

All India Institute of Medical Sciences, Rishikesh

deepak10.4u@gmail.com

Outcome results

None listed

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