To compare the efficacy of propofol monotherapy versus propofol-ketamine combination on peri-extubation outcomes in patients undergoing laparoscopic cholecystectomy under general anesthesia

To compare the effect of propofol alone versus propofol-ketamine combination on peri-extubation quality and hemodynamic stability in patients undergoing cholecystectomy under general anesthesia.

This will be a randomized, double-blind, active-controlled, parallel-group, phase 3 clinical trial conducted on 100 patients.

Randomized, double-blind clinical trial on 100 elective cholecystectomy patients at Al-Hussein and Bint Al-Hoda hospitals, Nasiriyah, Iraq. Two groups of 50: propofol alone vs. propofol-ketamine (simple randomization via Excel). Patient and data analyst blinded.

Inclusion: Age 18–65 years, ASA class I or II, elective cholecystectomy under general anesthesia, written informed consent. Exclusion: Severe cardiac/pulmonary/hepatic/renal/neurological disease, allergy to propofol or ketamine, psychiatric history/substance abuse, pregnancy/lactation, BMI >35, difficult airway, emergency surgery.

Group Propofol alone: Induction with propofol 2 mg/kg IV; maintenance with continuous propofol infusion of 100–150 µg/kg/min Group Propofol–Ketamine combination: Induction with propofol 2 mg/kg IV + ketamine 0.5 mg/kg IV; maintenance with continuous propofol infusion of 100–150 µg/kg/min (no additional ketamine)

Primary outcomes: Extubation quality (5-point score: coughing, agitation, breath-holding, laryngospasm) and hemodynamic parameters (HR, SBP, DBP, MAP) at baseline, induction, intubation, extubation, and 0, 5, 15, and 30 minutes post-extubation.

Eligible patients will be divided into two equal groups using the simple randomization method. A random number sequence will be generated using statistical software (such as SPSS or Excel) via the random number function (RANDBETWEEN). Odd numbers will be allocated to Group 1 (Propofol alone) and even numbers to Group 2 (Propofol–Ketamine combination). The allocation sequence will be prepared by an independent colleague who is not involved in the data collection process. To ensure allocation concealment, the group codes will be placed in sequentially numbered, opaque, sealed envelopes. After obtaining written informed consent and upon the patient's arrival in the operating room, the corresponding envelope will be opened, and the assigned intervention will be administered

This study will be conducted as a double-blind trial. The study drugs for both groups will be prepared by an independent colleague who is not involved in data collection, and will be provided to the anesthesiologist in identical, coded containers. The anesthesiologist will be aware of the drug composition due to the clinical necessity of knowing the type and dosage of the administered agent for safe anesthesia management. However, the patient will remain unaware of the treatment allocation, and the data analyst, who is responsible for the statistical analysis of the results, will remain blinded to the group codes until the completion of all analyses. Thus, blinding of the patient and the data analyst is maintained.

It is decided that individual participant data will not be publicly shared, and only the results of aggregate analyses will be published in the final article. The main reason for this decision is to protect the confidentiality and privacy of the participants. It should be noted that the initial informed consent form did not include permission for the publication and sharing of personal data of the patients. However, upon formal request from the journal in which the article will be published, the raw data may be made available to the journal's reviewers or editors, after complete removal of all identifiable information (such as names, surnames, contact numbers, and any personal identifiers), and will only be presented with hospital codes that have been assigned to each patient from the beginning of the study. No public dissemination of personal data will take place.

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