Study of two drugs melatonin and gabapentin for control of anxiety and stress response to anaesthesia.

Melatonin Vs Gabapentin as Premedication for Anxiolysis and Attenuation of Haemodynamic Response to Laryngoscopy and Intubation in General Anaesthesia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/10/028421

Enrollment

Registered

2020-10-15

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: 8- Other Procedures

Interventions

Intervention1: Secondary Outcome: 1.To study the role of melatonin and gabapentin as a sedative and analgesic when used as premedication. 2. To study anxiety , cognitive, psychomotor skills, orienta

Eligibility

Inclusion criteria

Inclusion criteria: o ASA grade 1 and 2 patients, o Age- 18 to 60 years o Elective surgery: major abdominal surgeries lasting for 2hrs or more. o GA

Exclusion criteria

Exclusion criteria: o Age 60years o ASA grade 3,4,5 o Emergency surgery o Patients on sedatives, antiepileptics, or antidepressants, anti psychotics, anxiolytics o obesity (BMI >= 28) o neuropsychiatric illness o anticipated difficult intubation o Pregnant and lactating females

Design outcomes

Primary

Measure	Time frame
Primary outcome: Compare role of melatonin and gabapentin as premedication for anxiolysis and attenuation of haemodynamic response to direct laryngoscopy and tracheal intubation.Timepoint: Pre operatively after drug administration at 0min, 30min and 60min assessment of anxiety, sedation, cognition, psychomotor function, orientation will be done. Intra operatively the pressor response will be assessed by measuring SBP, DBP, MAP, HR at 1, 5, 10, 30 and 60min and compared with a baseline measurement taken 5 min before intubation.	—

Measure

Time frame

Primary outcome: Compare role of melatonin and gabapentin as premedication for anxiolysis and attenuation of haemodynamic response to direct laryngoscopy and tracheal intubation.Timepoint: Pre operatively after drug administration at 0min, 30min and 60min assessment of anxiety, sedation, cognition, psychomotor function, orientation will be done. Intra operatively the pressor response will be assessed by measuring SBP, DBP, MAP, HR at 1, 5, 10, 30 and 60min and compared with a baseline measurement taken 5 min before intubation.

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Secondary

Measure	Time frame
1.To study the role of melatonin and gabapentin as a sedative and analgesic when used as a premedication. 2. To study anxiety , cognitive, psychomotor skills, orientation in pre op period memory & recall in post operative period. Timepoint: Post operatively the data of analgesic requirement of different groups is collected at the end of 24hrs and patientâ??s memory and recall are re assessed at the end of 24hrs.	—

Measure

Time frame

1.To study the role of melatonin and gabapentin as a sedative and analgesic when used as a premedication. 2. To study anxiety , cognitive, psychomotor skills, orientation in pre op period memory & recall in post operative period. Timepoint: Post operatively the data of analgesic requirement of different groups is collected at the end of 24hrs and patientâ??s memory and recall are re assessed at the end of 24hrs.

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Countries

India

Contacts

Public ContactDr Pradhan K

Dept of Anaesthesiology D Y Patil Medical College,Kolhapur

drkrk29@gmail.com9964837737

Outcome results

None listed

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