Study of Preemtive Analgestic effect of dexmedetomidine Versus ketamine on pain control after total laparoscopic hysterectomy - a randomized clinical trial study

To evaluate and compare demographic data, post-operative pain intensity, opioid consumption, side effects, quality of recovery, hospital stay duration, intraoperative vital signs, and extubation time among the three study groups.(ketamine,dexmedetomidine and control)

A randomized, double-blind, parallel-group, controlled phase III clinical trial was conducted on 120 patients. Randomization was performed using the card-shuffling method.

A randomized, double-blind clinical trial was conducted on 120 TLH patients at Hajar Hospital to compare dexmedetomidine and ketamine against a control. Drugs were administered 10 minutes before incision. Outcomes—including VAS pain scores, opioid use, vital signs, recovery quality, and hospital stay—were monitored for 24 hours postoperatively. Blinding was maintained for patients, anesthesiologists, and statisticians, with only the preparation nurse remaining unblinded.

A: Inclusion Criteria: Patients scheduled for Total Laparoscopic Hysterectomy (TLH). Patients with ASA physical status I or II. No history of addiction to benzodiazepines or opioids, including methadone. B: Exclusion Criteria: Prolonged surgical duration exceeding 180 minutes. Conversion of the surgical procedure to laparotomy. Requirement for blood transfusion during surgery.

In one group, ketamine at a dose of 0.5 mg/kg and in another group, dexmedetomidine at a dose of 0.5 microgram/kg are administered intravenously after induction of anesthesia and before the start of surgery. In the control group, an equivalent volume of normal saline Is administered

Postoperative pain intensity was assessed using the Visual Analog Scale (VAS) at 0, 30 minutes, 1 hour, and 4, 6, 12, and 24 hours post-surgery.

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.

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.

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.

From the date of publication until 5 years after publication.

Qualified researchers who provide a scientifically justified request and agree to data confidentiality requirements.

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.

Requests should be directed to the corresponding author via email and will be reviewed on a case-by-case basis.

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.