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The effects of premedication with pregabalin, diazepam or placebo on preoperative anxiety : A randomized controlled trial

The effects of premedication with pregabalin, diazepam or placebo on preoperative anxiety : A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
TCTR
Registry ID
TCTR20190424001
Enrollment
231
Registered
2019-04-24
Start date
2019-08-29
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

preoperative anxiety pregabalin diazepam preoperative anxiety

Interventions

Group P &#45
The night before surgery&#44
patient receive pregabalin 75 mg 1 capsule and placebo of diazepam 5 mg 1 capsule &#45
2 hours before surgery&#44
patient receive pregabalin 75 mg 2 capsule and placebo of diazepam 5 mg 2 capsule,Group D &#45
patient receive placebo of pregabalin 75 mg 1 capsule and diazepam 5 mg 1 capsule &#45
patient receive placebo of pregabalin 75 mg 2 capsule and diazepam 5 mg 2 capsule,Group C &#45
patient receive placebo of pregabalin 75 mg 1 capsule and placebo of diazepam 5 mg 1 capsule &#45
patient receive placebo of pregabalin 75 mg 2 capsule and placebo of diazepam 5 mg 2 capsule
Experimental Drug,Experimental Drug,Experimental Drug
Group P,Group D,Group C

Sponsors

Department of anesthesiology, Faculty of Medicine, Prince of Songkla University
Lead Sponsor
ืnone
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients undergoing elective surgery at songklanagarind hospital under general anesthesia or regional anesthesia 2. Age between 18 – 70 year-old 3. American Society of Anesthesiologists (ASA) classification I-II

Exclusion criteria

Exclusion criteria: 1. Inability to understand Thai or to provide informed consent 2. Known pregabaline or diazepam allergy 3. Regular use of pregabalin or diazepam 4. Pregnant or breast feeding 5. Known kidney(CrCl 35kg/m2) 10. History of drug abuse 11. Risk of aspiration 12. Risk of difficult airway 13. Enrollment in other study

Design outcomes

Primary

MeasureTime frame
Preoperative anxiety the evening before surgery, before anaesthesia induction Numerical rating scale for anxiety 0-10 , STAI-state, APAIS—

Secondary

MeasureTime frame
Incident of preoperative anxiety in songklanagarind hospital the evening before surgery Incident in percentage,factor associated with preoperative anxiety all time point Correlation Analysis ,sleep quality before anaesthesia induction numerical rating scale 0-10,postoperative analgesia postoperative period at recovery room numerical rating scale 0-10—

Countries

hatyai

Contacts

Public ContactBenjalak charoenporn

Unaffiliated

benjalak.c@psu.ac.th0807091155

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026