Condition 1: Acute ACL tear - right knee. Condition 2: Acute ACL tear - left knee. Sprain of anterior cruciate ligament of right knee, initial encounter Sprain of anterior cruciate ligament of left knee, initial encounter
Conditions
Interventions
Intervention 1: Intervention Group: Patients undergoing ACL reconstruction surgery who receive fentanyl and midazolam as needed during the procedure, based on the anesthesiologist’s judgment. Interven
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Indication for unilateral anterior cruciate ligament repair surgery Informed consent to participate in the clinical trial Age between 18 to 65 years
Exclusion criteria
Exclusion criteria: Uncontrolled systemic diseases History of seizure History of migraine History of inner ear or middle ear dysfunction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The amount of anesthetic drug administered to the patient. Timepoint: After entering the operation room and during the surgical procedure. Method of measurement: The amount of Midazolam or Fentanyl injected to the patient as recorded in the surgery report note. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain. Timepoint: 10 minutes after the patient is recovered in the post-anesthesia care unit (PACU). Method of measurement: Visual Analogue Scale (VAS).;Anxiety during surgery. Timepoint: 10 minutes after the patient is recovered in the post-anesthesia care unit (PACU). Method of measurement: Hospital Anxiety and Depression Scale (HADS).;Patient satisfaction. Timepoint: 10 minutes after the patient is recovered in the post-anesthesia care unit (PACU). Method of measurement: Visual Analogue Scale (VAS). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Hossein Mahrooz
Shahid Beheshti University of Medical Sciences
Outcome results
None listed