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To find whether amitriptyline, an anti-depressant can reduce the anxiety of surgery and decrease the pain following surgery

Evaluation of the effect of amitriptyline premedication on preoperative anxiety and postoperative pain - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/10/058824
Enrollment
96
Registered
2023-10-18
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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: NIL: NIL

Sponsors

K S Hegde Medical Academy
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients belonging to American Society of Anaesthesiologist Physical Status (ASA PS) 1 and 2, undergoing elective surgeries under general anaesthesia

Exclusion criteria

Exclusion criteria: 1)Scheduled for emergency surgery 2)Hypersensitivity to the drug 3)History of QT prolongation, arrhythmias, recent myocardial infarction or heart failure 4)Patients with angle-closure glaucoma, urinary retention, seizures 5)Patients on monoamine oxidase inhibitors (MAOI) within last 14 days 6)Patients on drugs that can increase QT interval such as cisapride, pentamidine, procainamide, quinidine, sotalol, terfenadine 7)Renal and hepatic impairment 8)Pregnancy 9)Psychiatry patient and patient who are not able to understand instructions

Design outcomes

Primary

MeasureTime frame
To evaluate preoperative anxiety with amitriptyline premedication To evaluate postoperative pain reduction with amitriptyline premedication in terms of a) Pain intensity b) Amount of postoperative opioid consumptionTimepoint: Anxiety measured using ALS prior to the pre-anaesthetic evaluation (ALS1), prior to the use of amitriptyline (ALS2) and 2 hour post amitriptyline use (ALS3). Post-operative HR, SBP, DBP, MAP, SpO2 will be noted every 15 min for the first hour and at 4th, 8th, 12th and 24th hour in postoperative period Pain score in postoperative period will be assessed using VAS at 4th, 8th, 12th, 24th hours. Total amount of opioid consumed will also be recorded postoperatively.

Secondary

MeasureTime frame
Evaluate the effect of amitriptyline premedication on a) Sedation b) Any other adverse effects Timepoint: Brussels sedation score will be assessed one hour after premedication and in the postoperative period.Any adverse effects such as arrhythmia, post-operative nausea and vomiting and dryness of mouth.

Countries

India

Contacts

Public ContactDr Sumalatha R Shetty

K S Hegde Medical Academy

sumarshetty@gmail.com9448115617

Outcome results

None listed

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