Comparing the two anesthetic drugs ( ketamine and dexmedetomidine) during the operative period in reducing the analgesic drug (opioid) requirement during the operative period using Surgical Plethysmo graphic Index (SPI) based nociception monitoring in patients undergoing lumbar spine surgeries.

Comparison of intraoperative infusion of subanaesthetic ketamine and dexmedetomidine in reducing opioid requirement during the intraoperative period using Surgical Plethysmo graphic Index (SPI) based nociception monitoring in patients undergoing lumbar spine surgeries.

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/01/048710

Enrollment

Registered

2023-01-03

Start date

Unknown

Completion date

Unknown

Last updated

2025-07-21

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 D (Dexmedetomidine): Once the patient is turned prone the dexmedetomidine drug (bolus) will be administered over 10 min. Patients in group group D will receive dexmedetomidine 0.5

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patient aged 18-70 years belonging to either sex. 2. American society of anesthesiologists.

Exclusion criteria

Exclusion criteria: 1. Allergy to any of the drugs used in the study including ketamine and dexmedetomidine. 2. Raised intracranial and intraocular pressure. 3. ischemic heart disease and uncontrolled hy-pertension. 4. History of psychosis and seizure disorder. 5. Hepatic and renal impairment. 6. History of possibility of postoperative delir-ium patients (eg: delirium tremons, possibility of head trauma). 7.History of Porphyria disorder.

Design outcomes

Primary

Measure	Time frame
Comparison of intraoperative fentanyl requirement between the groups based on SPI based nociception monitoring.Timepoint: Intraoperative period	—

Secondary

Measure	Time frame
Comparison of the time to extubating between the groups. Timepoint: Intraoperative period;Comparison of recovery characteristics between the groups using Quality of Recovery15 (QoR15) score at the end of 24 hours in the postoperative period. Timepoint: Postoperative period;Comparison of the total fentanyl consumption between the groups during the first 24hrs in the postoperative period using patient-controlled analgesia. Timepoint: Postoperative period	—

Measure

Time frame

Comparison of the time to extubating between the groups. Timepoint: Intraoperative period;Comparison of recovery characteristics between the groups using Quality of Recovery15 (QoR15) score at the end of 24 hours in the postoperative period. Timepoint: Postoperative period;Comparison of the total fentanyl consumption between the groups during the first 24hrs in the postoperative period using patient-controlled analgesia. Timepoint: Postoperative period

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Countries

India

Contacts

Public ContactDr Srinivasan S

Jawaharlal Institute of Postgraduate Medical Education and Research

jipmersrinivasan@gmail.com9626493045

Outcome results

None listed

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