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IRCT20190127042511N3 IRCT 2026-06-10 Shahre-kord University of Medical Sciences A comparative study of the effects of ketamine and dexmedetomidine on pain after hysterectomy Study of Preemtive Analgestic effect of dexmedetomidine Versus ketamine on pain control after total laparoscopic hysterectomy - a randomized clinical trial study 2026-06-22 anticipated 120 Recruiting https://irct.ir/trial/90401 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Sampling was performed by convenience sampling. Patients who met the inclusion criteria were enrolled in the study and then randomly assigned to three groups: K, D, and control. For randomization, the card-shuffling method was used. In this method, a number of cards was selected by the researcher for the first group, and the same number of cards was considered for the subsequent groups. The cards were then mixed together (shuffled), one card was drawn, and its allocation was recorded. After being drawn, the card was returned to the set of cards. The cards were then reshuffled, and another card was drawn. This process continued until a random sequence corresponding to the sample size was obtained. One of the advantages of this method is its practicality for multigroup studies. Olson et al. also used this method for randomization in their study, Blinding description: To maintain the double-blind nature of the study, a coding method was used so that neither the performing physician nor the patient was aware of the type of intervention. The medications were prepared and administered by a trained nurse who was not involved in any other part of the study, and the coding procedure was also performed by this nurse. The blinding process was carried out as follows: 1. Individuals blinded to the intervention Patients: were unaware of the type of intervention administered (active drug or placebo). The physician performing the procedure: was blinded to the type of intervention and the composition of the medication contained in the syringes. The statistical analyst: did not have access to the group allocation codes until completion of the primary analysis. 2. Individuals aware of the intervention type Only one trained nurse, who had no role in treatment administration, sampling, patient monitoring, or outcome assessment, was aware of the group allocations. This individual was solely responsible for preparing the medications and coding the syringes and had no involvement in any other stage of the study. 3. Preparation and coding procedure The non-involved nurse prepared the active drug or placebo according to the randomization list. Each syringe was labeled with a unique numerical code without any identifying marks. The volume, color, and appearance of the drug and placebo were made identical to prevent recognition by either the patient or the physician. The correspondence table between the code and intervention type was kept in a sealed envelope and was opened only after completion of data collection. 4. Injection procedure The physician received only the coded syringe and had no information about its contents. The patient also received no information regarding the type of intervention, and the appearance of all syringes was completely identical. 3 Study of Preemtive Analgestic effect of dexmedetomidine Versus ketamine on pain control after total laparoscopic hysterectomy. Intervention 1: In the first intervention group, general anesthesia is induced using midazolam (0.1 mg/kg), propofol (2.5 mg/kg), fentanyl (3 . Intervention 2: “In the second intervention group, general anesthesia was induced using midazolam (0.1 mg/kg), propofol (2.5 mg/kg), fentanyl (3 . Intervention 3: In the control group, general anesthesia was induced using midazolam (0.1 mg/kg), propofol (2.5 mg/kg), fentanyl (3 . Yes - There is a plan to make this available What will be shared: De-identified raw dataset containing the variables used for statistical analyses in the present study. All direct patient identifiers will be removed prior to data sharing. When: From the date of publication until 5 years after publication. To whom: Qualified researchers who provide a scientifically justified request and agree to data confidentiality requirements. Conditions: Data will be available for research and educational purposes only. Commercial use is prohibited. Recipients must agree not to attempt re-identification of study participants. Where to obtain: Requests should be directed to the corresponding author via email and will be reviewed on a case-by-case basis. How to obtain: Requests for access to the data should be submitted in writing to the corresponding author. Requests will be reviewed by the research team for scientific merit, consistency with the study objectives, and compliance with ethical requirements. Upon approval, applicants will be required to sign a Data Use Agreement, after which de-identified data will be made available. Comments:
public Alireza Babaeizadeh
Parastar St., Hajar Hospital
Shahrekord Iran (Islamic Republic of) ۸۸۱۶۷۵۴۶۳۳ +98 38 2223 0016 babaeizadeh.a@skums.ac.ir Shahre-kord University of Medical Sciences scientific Alireza Babaeizadeh
Parastar St., Hajar Hospital
Shahrekord Iran (Islamic Republic of) ۸۸۱۶۷۵۴۶۳۳ +98 38 2223 0016 babaeizadeh.a@skums.ac.ir Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Patients undergoing Total Laparoscopic Hysterectomy (TLH). Patients with an American Society of Anesthesiologists (ASA) physical status classification of I or II. No history of addiction to benzodiazepines or opioids (including methadone). no limit no limit Female Prolonged surgery duration (exceeding 180 minutes). Conversion from laparoscopic to open surgery (laparotomy). Requirement for blood transfusion during surgery. Prevention Prevention Placebo In the first intervention group, general anesthesia is induced using midazolam (0.1 mg/kg), propofol (2.5 mg/kg), fentanyl (3 “In the second intervention group, general anesthesia was induced using midazolam (0.1 mg/kg), propofol (2.5 mg/kg), fentanyl (3 In the control group, general anesthesia was induced using midazolam (0.1 mg/kg), propofol (2.5 mg/kg), fentanyl (3 Postoperative pain intensity, measured via the Visual Analog Scale (VAS), was evaluated at 0, 30 minutes, and 1 hour post-surgery, and at 4, 6, 12, and 24 hours after transfer to the ward, across the dexmedetomidine, ketamine, and control groups. Timepoint: at 0, 30 minutes, and 1 hour postoperatively, and at 4, 6, 12, and 24 hours following ward transfer in the dexmedetomidine, ketamine, and control groups. Method of measurement: Visual Analog Scalescores were assessed on a scale of 0–10 at the indicated time points. Total opioid consumption. Timepoint: Total fentanyl or pethidine consumption over 24 hours. Method of measurement: miligram. Postoperative adverse effects. Timepoint: Postoperative adverse effects, including nausea, vomiting, hypotension, and bradycardia, were monitored in all groups. Method of measurement: Based on the yes/no responses. Length of hospital stay. Timepoint: Duration of stay until discharge after surgery. Method of measurement: Time to discharge, measured in days or hours. Vital sign. Timepoint: Every 15 minutes during the procedure. Method of measurement: Using a monitoring device (blood oxygen saturation, blood pressure in mmHg, and heart rate in beats per minute). Quality of recovery. Timepoint: At the time of discharge from recovery. Method of measurement: Aldrete score. Extubation time. Timepoint: Time from discontinuation of the anesthetic agent to extubation. Method of measurement: Time from discontinuation of the anesthetic agent to extubation, measured in minutes. Reseach department Approved 2026-04-22 Research Ethics Committees of School of Medicine - Shahrekord University of Medical Sciences Parastar St., Hajar Hospital Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)