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IRCT20230626058586N12 IRCT 2026-01-03 Tehran University of Medical Sciences The effect of cannabidiol on sleep quality and pain reduction The Comparative Evaluation of the Impact of Cannabidiol Administration Versus Non-Administration on Sleep Quality and Pain Outcomes in Patients Undergoing Intermediate Elective Abdominal Surgery 2026-02-20 anticipated 50 Recruiting https://irct.ir/trial/87941 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The website www.Randomization.com will be used for randomization (online, simple randomization). After determining the number of intervention groups, which are two groups, and the required number in each of these groups, the website will provide us with a random table of numbers that will represent the patient's number. Then the random sequence is available to the researcher. The researcher performs the desired intervention based on the order in which the participants entered the study, Blinding description: This study will be conducted as a double-blind trial, such that: patients will not know whether they are receiving cannabidiol or a placebo (sterile water). However, the study groups will be explained to the patients when obtaining informed consent. The person who measures and records outcomes, including pain levels and sleep quality, will also be unaware of the allocation of drug or placebo to the patients. The drug and placebo will be prepared in identical containers and packaging and will be coded; only the pharmacist, who does not participate in data analysis, will keep the codes. 2 Condition 1: Sleep quality. Condition 2: Postoperative Pain. Intervention 1: Intervention group: Administration of an oral solution (as drops) of cannabidiol at a concentration of 100 mg/mL and a dose of 25 mg (equivalent to 0.25 mL of the solution) will be given as a single dose at the start of anesthesia induction before the surgical procedure, which the patient will orally ingest. The solution brand is CannaPure CBD Oral Solution, manufactured by CannaPure Pharmaceuticals Ltd. Intervention 2: Control group: Administration of an oral solution (drops) of sterile water will be given as a single dose at the start of anesthesia induction before the surgical procedure, which the patient will orally ingest. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Kasra Karvandian
Imam Khomeini hospital, Keshavarz blvd.
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ +98 21 6658 1625 karvandian@tums.ac.ir Tehran University of Medical Sciences scientific Kasra Karvandian
Imam Khomeini hospital, Keshavarz blvd.
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ +98 21 6658 1625 karvandian@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients Undergoing Intermediate Elective Abdominal Surgery Age between 18 and 65 years American Society of Anesthesiologists (ASA class) II/III Patient satisfaction 18 years 65 years Both Addicted patients Patients with a history of psychiatric disorders and sleep disturbances F51.8 G89.18 Other sleep disorders not due to a substance or known physiological condition Other acute postprocedural pain Prevention Prevention Intervention group: Administration of an oral solution (as drops) of cannabidiol at a concentration of 100 mg/mL and a dose of 25 mg (equivalent to 0.25 mL of the solution) will be given as a single dose at the start of anesthesia induction before the surgical procedure, which the patient will orally ingest. The solution brand is CannaPure CBD Oral Solution, manufactured by CannaPure Pharmaceuticals Ltd. Control group: Administration of an oral solution (drops) of sterile water will be given as a single dose at the start of anesthesia induction before the surgical procedure, which the patient will orally ingest. Post operative sleep quality. Timepoint: Once after the intervention (after recovery). Method of measurement: Using the Richards-Campbell Sleep Questionnaire (RCSQ). Post operative pain. Timepoint: At four time points: namely 1 hour, 2 hours, 4 hours, and 8 hours after the intervention. Method of measurement: Visual Analog Survey Scale. Tehran University of Medical Sciences Approved 2025-12-02 The Ethics Committee of Imam Khomeini Hospital Complex, Tehran University of Medical Sciences Ethics Committee of the Imam Khomeini Hospital Complex, Office of the Deputy for Research, southwest wing, Imam Khomeini Hospital Complex, End of Keshavarz Boulevard. Tehran Tehran Iran (Islamic Republic of)