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

Comparison of the effect of administering versus not administering cannabidiol on sleep quality and pain relief in patients undergoing intermediate elective abdominal surgery.

This clinical trial is a randomized, parallel-group, double-blind study with a control group, in which participants will be assigned to one of the two groups using a simple online randomization method. The study is a Phase II trial involving 50 patients.

The target population consists of patients referred to Imam Khomeini Center for elective intermediate abdominal surgery. Participants will be randomly assigned to one of the two groups using an online randomization method. The study is double-blind, with both the patient and the outcome assessor evaluating sleep quality and pain being unaware of whether cannabidiol or sterile water has been administered.

Inclusion criteria: Patients undergoing intermediate elective abdominal surgery, aged 18–65 years, American Society of Anesthesiologists (ASA) class II/III, and willing to provide informed consent. Exclusion criteria: Patients with substance abuse, a history of psychiatric disorders, or sleep disturbances.

Intervention group: Administration of 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) as a single dose at the start of 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 at the start of anesthesia induction before the surgical procedure, which the patient will orally ingest.

Patients’ sleep quality and Pain intensity

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.

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.