The effect of premedication with Valiflore on preoperative anxiety

Randomized double-blinded clinical trial: The effect of premedication with Valiflore on preoperative anxiety compared with placebo in patients undergoing elective laparoscopic cholecystectomy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201404115175N13

Enrollment

Registered

2014-05-18

Start date

2014-05-19

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Anxiety. Generalized anxiety disorder

Interventions

Intervention 1: Patients in the intervention group (number=40) receive a valiflore tablet orally 2 hours before the surgery. Intervention 2: Patients in the control group (number=40) receive a placebo

Prevention

Placebo

Patients in the intervention group (number=40) receive a valiflore tablet orally 2 hours before the surgery.

Patients in the control group (number=40) receive a placebo tablet orally 2 hours before the surgery. placebo tablet is similar to the original drug in color, odor and shape.

Eligibility

Sex/Gender

All

Age

20 Years to 55 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients at the age of 20-55; American Society of Anesthesiologists class I, II; Patients undergoing surgical laparoscopic cholecystectomy. Exclusion criteria: Patients with a history of anxiety disorders and other mental disorders; Patients with a drug history of sedative drugs; Analgesic; Anti-depressant and anti-seizure; Patients with Numerical Rating Scale for anxiety less than 1.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Anxiety. Timepoint: Before administration of premedication, 15 minutes, 30 minutes, 60 minutes, 90 minutes and 120 minutes after administration of premedication. Method of measurement: Numeric Rating Scale.	—

Secondary

Measure	Time frame
Sedation. Timepoint: Before administration of premedication, 15 minutes, 30 minutes, 60 minutes, 90 minutes and 120 minutes after administration of premedication. Method of measurement: Ramsey Sedation Scale.;Duration of anesthesia. Timepoint: First minute of anesthetia, first minute of recovery. Method of measurement: Time in minute.;Duration of surgery. Timepoint: First minute of starting surgery, minute of finishing surgery. Method of measurement: Time in minute.;Duration of departure time of recovery. Timepoint: First minute of entering recovery, minute of departure of recovery. Method of measurement: Time in minute.	—

Measure

Time frame

Sedation. Timepoint: Before administration of premedication, 15 minutes, 30 minutes, 60 minutes, 90 minutes and 120 minutes after administration of premedication. Method of measurement: Ramsey Sedation Scale.;Duration of anesthesia. Timepoint: First minute of anesthetia, first minute of recovery. Method of measurement: Time in minute.;Duration of surgery. Timepoint: First minute of starting surgery, minute of finishing surgery. Method of measurement: Time in minute.;Duration of departure time of recovery. Timepoint: First minute of entering recovery, minute of departure of recovery. Method of measurement: Time in minute.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Ali Movafegh

Tehran University of Medical Sciences

movafegh@sina.tums.ac.ir+98 21 8490 2397

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 26, 2026