To find whether amitriptyline, an anti-depressant can reduce the anxiety of surgery and decrease the pain following surgery
Not Applicable
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2023/10/058824
- Lead Sponsor
- K S Hegde Medical Academy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate preoperative anxiety with amitriptyline premedication <br/ ><br>To evaluate postoperative pain reduction with amitriptyline premedication in terms of <br/ ><br>a) Pain intensity <br/ ><br>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 <br/ ><br>and at 4th, 8th, 12th and 24th hour in postoperative period <br/ ><br>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 <br/ ><br>postoperatively. <br/ ><br>
- Secondary Outcome Measures
Name Time Method Evaluate the effect of amitriptyline premedication on <br/ ><br>a) Sedation <br/ ><br>b) Any other adverse effects <br/ ><br>Timepoint: Brussels sedation score will be assessed one hour after premedication and in the <br/ ><br>postoperative period.Any adverse effects such as arrhythmia, post-operative nausea and vomiting and dryness of mouth.