Comparison of the sedation and analgesia effect of intrathecal dexmedetomidine, fentanyl and neostigmine in femur fracture repair surgery

Comparison of the sedation and analgesia effect of intrathecal dexmedetomidine, fentanyl and neostigmine in femur fracture repair surgery

The present study is a double-blind, parallel-group, randomized clinical trial (using block randomization) on 135 patients.

In this double-blind randomized clinical trial, patients who are candidates for hip fracture repair surgery and referred to Valiasr Hospital in Arak will be divided into three equal treatment groups of dexmedetomidine, fentanyl, and neostigmine by block randomization. In this study, patients will be blinded to anesthesia and outcome assessor (by patient coding). Finally, the three groups will be evaluated for study outcomes.

Inclusion criteria: Patients who are candidates for surgery to repair a femur fracture and refer to Vali Asr Hospital in Arak; Consent to participate in the study; BMI less than 30; ASA class 1 and 2. Exclusion criteria: Presence of kidney, liver, heart disease and cardiac arrhythmias; Sensitivity to the drugs used; Psychological problems and absence of peripheral and central neuropathy; Local infection in the spinal area.

Dexmedetomidine group: Patients received 5 micrograms of dexmedetomidine (in a volume of 1 ml) with 15 mg of ropivacaine (3 ml of ropivacaine 0.5%) intrathecally. Fentanyl group: Patients received 50 micrograms of fentanyl (1 ml) with 15 mg of ropivacaine (3 ml of ropivacaine 0.5%) intrathecally. Neostigmine group: Patients received 50 mg of neostigmine (in a volume of 1 ml) with 15 mg of ropivacaine (3 ml of ropivacaine 0.5%) intrathecally.

Onset of sensory and motor block, pain score, mean arterial pressure, heart rate, arterial oxygen saturation, duration of sensory and motor block, postoperative complications, mean narcotics consumed

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 9 will be used to allocate samples. Thus, using the site www.sealedenvelope.com, blocks of 9 letters A, B, and C will be randomly generated based on the sample size. The order of the letters A, B, and C in each block from the first block to the last block is considered as the randomization sequence. The generation of these blocks and their random sequence is entirely done by this site and the researcher is not aware of their sequence.

This study will be based on a double-blind design. In this way, the anesthesiologist performing spinal anesthesia is aware of the patient grouping, but the patients and the intern who is responsible for collecting the data are unaware of the groupings, and finally the relevant intern will record the clinical information and outcomes of each patient and deliver it to the statistician. Patients who are anesthetized and are not aware of the medication they receive. Therefore, in this study, it can be stated that the patients and the intern evaluating the data are unaware of the groupings.

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 2025/06/20 to 2028/06/20 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.

University researchers and university professors can request Dr. Ahmadreza Behrouzi to use the data after contacting the relevant professor via message or email. Dr. Hesamuddin Modiri: Phone: 09183615107 Email: modir.he@gmail.com, Address: Valiasr Hospital, Arak, Vice-Chancellor of Hospital Education

Letter writing should be done with professors and universities.