Comparison of remifentanil, Apotel (Paracetamol) and dexmedetomidine in postoperative pain control of abdominal hysterectomy candidates

Comparison of the effects of remifentanil, Apotel, and dexmedetomidine on pain control after abdominal hysterectomy.

The present study is a double‑blind, randomized, parallel‑group clinical trial (using block randomization) conducted on 195 patients.

In this randomized double‑blind clinical trial, patients scheduled for abdominal hysterectomy at Arak Sina Ashtiani Hospital will be randomly assigned using block randomization into three groups (A, B, and C). Blinding will be implemented by labeling the drug syringes and coding the patients. Finally, the study outcomes will be compared between the two groups.

Inclusion criteria: Patients scheduled for hysterectomy presenting to Sina Ashtiani Hospital; possession of a signed written informed consent; American Society of Anesthesiologists (ASA) Physical Status Classification, classes I and II. Exclusion criteria: Presence of systemic diseases including renal, hepatic, cardiovascular disorders, hypertension, diabetes, or malignancy; history of substance abuse or chronic analgesic consumption; presence of known hypersensitivity to any of the study drugs and a history of seasonal allergy.

In intervention group 1, patients will receive 1 g Apotel, 16 mg dexamethasone, 16 mg ondansetron, and 10 mg morphine. In intervention group 2, patients will receive 16 mg dexamethasone, 16 mg ondansetron, 10 mg morphine, and 30 µg dexmedetomidine. In intervention group 3, patients will receive 16 mg dexamethasone, 16 mg ondansetron, 10 mg morphine, and 1 g remifentanil.

Duration of analgesia, mean arterial pressure, heart rate, arterial oxygen saturation, opioid consumption, pain score.

Participants will be assigned to three intervention groups in order of arrival and based on a randomization sequence that will be generated in advance. This sequence is unpredictable and its arrangement is completely random. A block randomization method with blocks of 6 will be used to allocate the samples. Thus, using the block random number generation software, a randomization sequence proportional to the required sample size will be generated for the three groups. Initially, all the cases in which the 3 letters A, B, and C can be arranged together in a block of 6 are performed. Then, a block is randomly selected from the blocks by placement, and the arrangement pattern in that block will be used to allocate the participants. Then this block is placed in the main container and another block will be selected again. All these steps will be performed with a software called Sealed Envelope. Concealment will also be observed using this method. The concept of concealment is to make the assignment of individuals to groups unpredictable. In fact, the researcher will not be able to predict which group the next person will be placed in.

This study will be conducted in a double‑blind design. None of the patients will be aware of the type of drug they receive. The drugs will be administered to the patients by the anesthesiologist. The injection syringes will be labeled with the patient’s medical record number, without disclosure of their contents; therefore, patients will not know the type of injectable medication. The assigned intern responsible for recording outcomes will not be aware of the patients’ group allocation, will evaluate them based on their medical record number, and will hand over the collected data to the corresponding anesthesiologist. Consequently, the intern will have no knowledge of the patients’ group assignment or prescribed drugs.

After conducting this study and analytical studies on it, only a part of the data such as information about the main outcome and patient demographic information will be published to the researchers who do the necessary correspondence with the person in charge of this study.

Access will be from 2026/2/21 to 2029/2/21 for 3 years.

University researchers

Academic researchers or university professors or students who intend to use the data of this study, after obtaining permission from the relevant people mentioned, can use the information of this study in the field of metallurgical studies or other relevant review studies. In addition, if requested, they can use the information of this study for the prerequisites of their future studies and the existence of questions and ambiguities. Using the information of this study is subject to mentioning the names and logos of the responsible persons in this study.

Academic researchers and university faculty members, following initial contact via message or email with the relevant professor, may request access to and use of data from Dr. Alireza Kamali. Dr. Alireza Kamali, Phone: +98‑918‑162‑2810, Email: alikamaliir@yahoo.com, Address: Department of Education, Valiasr Hospital, Arak, Iran

Letter writing should be done with professors and universities.