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QUALITY OF RECOVERY AFTER SPINE SURGERY AND MELATONIN

EFFECT OF MELATONIN PREMEDICATION ON QUALITY OF RECOVERY IN PATIENTS UNDERGOING COMPLEX SPINE SURGERIES UNDER NEUROMONITORING:AN EXPLORATORY STUDY

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/11/029002
Enrollment
70
Registered
2020-11-09
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: S30-S39- Injuries to the abdomen, lower back, lumbar spine, pelvis and external genitals Health Condition 2: M41- Scoliosis

Interventions

Intervention1: RANDOMIZED CONTROLLED TRIAL: STUDY CONSIST OF TWO GROUPS/ARMS both undergoing complex spine surgeries under neuromonitoring: GROUP 1- Will receive tab melatonin 5mg night before and 2

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)18 to 65 years of age and undergoing complex spine surgeries under neuromonitoring- 2)ASA-I and II 3)Patients of either sex

Exclusion criteria

Exclusion criteria: 1)Patients not willing to participate 2)Significant Cardiac,Renal or Hepatic dysfunction 3)Allergy to the study drug 4)Patients with history of chronic use of sedatives or analgesics especially Opioids and Gabapentenoids 5)Patients requiring post operative ventilatory support 6)Patients with preoperative neurological deficit

Design outcomes

Primary

MeasureTime frame
TO DETERMINE QUALITY OF RECOVERY AS EVALUATED BY QOR15 SCORE AT 1 HOUR,6 HOURS AND 24 HOURS AFTER SURGERYTimepoint: 1 HOUR,6 HOURS AND 24 HOURS POST OPERATIVELY

Secondary

MeasureTime frame
1)TO EVALUAtE PREOPERATIVE ANXIETY AND SEDATION SCORE 2)TO EVALUATE PERIOPERATIVE HAEMODYNAMIC CHANGES 3)TO EVALUATE PAIN SCORE(VAS) AT 6 HOURS AFTER SURGERYTimepoint: PREOPERATIVE,PERIOPERATIVE AND 6 HOURS AFTER SURGERY

Countries

India

Contacts

Public ContactDR SANJAY AGRAWAL

AIIMS RISHIKESH

sanjay.anaes@aiimsrishikesh.edu.in9761712630

Outcome results

None listed

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