To Compare Keto-dex and fentanyl infusions (both used for sedation and pain relief) for relief of pain in the postoperative period after spine surgery

COMPARISON OF INTRA-OPERATIVE LOW DOSE KETO-DEX AND FENTANYL INFUSION FOR POST-OPERATIVE ANALGESIA IN SPINE SURGERY - A PROSPECTIVE RANDOMISED DOUBLE BLIND STUDY

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/03/031999

Enrollment

Registered

2021-03-15

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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: Low dose Keto-dex infusion for pot-operative analgesia in patients undergoing spine surgery.: Patient will be induced with KETODEX (ketamine 1 mg/kg, dexmedetomidine 1 mcg/kg over 10 m

Eligibility

Inclusion criteria

Inclusion criteria: ASA I and II patients belonging to both sexes undergoing more than 2 level thoracic-lumbar spine surgery.

Exclusion criteria

Exclusion criteria: Patients with Severe Hypertension, Coronary heart disease. Heart block, Patients on alpha 2 agonist or beta blockers, ASA III/IV patients, Known allergy to either drugs, Liver or renal disease, Raised ICP, pregnancy and Refusal to give consent.

Design outcomes

Primary

Measure	Time frame
To compare the perioperative analgesic requirements for first 24 hours after administration of intraoperative low dose KETODEX and fentanyl infusion in patients undergoing thoraco-lumbar spine surgery.Timepoint: 0, 4, 8, 12, 16, 20 and 24 hours	—

Secondary

Measure	Time frame
To compare the intra-operative anaesthetic requirements in both the groups, To compare haemodynamic parameters such as heart rate (HR) and mean arterial pressure (MAP) among both the groups, Any side effects of study drugs in first 24 hours after surgery, Ã?Â§ The duration of PACU (Post-anaesthesia recovery unit) stay in both the groups. Timepoint: Every 5 minutes for the intraoperative anaesthetic requirement. Every 5 for HR and MAP (Haemodynamics) in the intraoperative period. Any side effects for the first 24 hours Duration of PACU stay after surgery is over.	—

Measure

Time frame

To compare the intra-operative anaesthetic requirements in both the groups, To compare haemodynamic parameters such as heart rate (HR) and mean arterial pressure (MAP) among both the groups, Any side effects of study drugs in first 24 hours after surgery, Ã?Â§ The duration of PACU (Post-anaesthesia recovery unit) stay in both the groups. Timepoint: Every 5 minutes for the intraoperative anaesthetic requirement. Every 5 for HR and MAP (Haemodynamics) in the intraoperative period. Any side effects for the first 24 hours Duration of PACU stay after surgery is over.

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Countries

India

Contacts

Public ContactAnkur Luthra

PGIMER, Chandigarh

zazzydude979@gmail.com9868057732

Outcome results

None listed

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