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Effect of Midazolam Given at Induction on Recall of Propofol Injection Pain
Sponsor: Atlas University
Summary
Propofol is the most commonly used intravenous drug to start general anesthesia (induction). However, it often causes pain in the arm during injection, and remembering this pain after surgery can negatively affect the patient's experience and comfort. Adding lidocaine (a local anesthetic) to propofol reduces this pain but does not prevent it in every patient. Midazolam is a medicine commonly given to reduce anxiety, and it can also reduce the memory of events that occur after it is given (anterograde amnesia). It is not known whether midazolam reduces the memory of propofol injection pain after surgery. In this study, adult volunteers aged 18 to 65 who are scheduled for elective surgery will be randomly assigned to one of three groups: (1) a low sedative dose of midazolam before propofol, (2) propofol mixed with lidocaine, or (3) propofol alone. Neither the participants nor the investigator giving the medication will know which group a participant is in. After surgery, once participants have recovered sufficiently, they will be asked whether they remember pain at the injection site during propofol injection. The study will also assess the severity of injection pain and the relationship between anxiety before surgery and injection pain. All drugs used in this study are approved medicines given at doses used in routine anesthesia practice.
Official title: Effects of Midazolam Administered at Induction on the Recall of Propofol Injection Pain: A Prospective, Randomized, Controlled, Double-Blind Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2026-12-01
Completion Date
2027-03-01
Last Updated
2026-11-03
Healthy Volunteers
No
Interventions
Midazolam
Single intravenous dose of midazolam at an age-adjusted sedative dose (0.06 mg/kg for ages 18-30, 0.05 mg/kg for ages 31-50, 0.04 mg/kg for ages 51-65), diluted with 0.9% sodium chloride to a total volume of 5 mL and given before induction of anesthesia with propofol.
Lidocaine Hydrochloride 2%
Lidocaine 2% (total 40 mg) mixed in the same syringe with propofol 1% (200 mg propofol : 40 mg lidocaine) and given intravenously as a single dose during induction.
Propofol 1%
Propofol 1% (10 mg/mL), 2-3 mg/kg administered intravenously over 30 seconds through a 20 G dorsal hand vein catheter as the standard induction agent in all groups.
Sodium Chloride 0.9%
5 mL of 0.9% sodium chloride given intravenously before propofol induction as a carrier/placebo solution to maintain blinding.
Locations (1)
Istanbul Atlas University Faculty of Medicine Hospital
Istanbul, Turkey (Türkiye)