Comparison of the effect of Intrathecal addition of Dexmedetomidine and Sufentanil to Bupivacaine in Patients Undergoing Knee Prosthesis under Spinal Anesthesia: a Double-blind Randomized Clinical Trial

Comparison of the effect of intrathecal addition of dexmedetomidine and sufentanil to bupivacaine in patients undergoing knee prosthesis by spinal anesthesia

double-blind randomized clinical trial, phase 3 on 90 patients, web-based randomization software was used for randomization.

The present study is a double-blind clinical trial that will be performed on patients aged 40 to 70 years referred to Imam Ali (AS) Teaching Hospital in Bojnourd. Patients are randomly assigned to three groups (two interventions and control) blocked by a web-based system. The level and duration of analgesia will be assessed by a measuring instrument. To perform blinding, patients and the person performing the pain assessment work at different intervals will be blinded to the groups.

Inclusion criteria: Patients be vigilant. Do not Have history of previous surgery. Do not Have history of taking anti-anxiety, analgesic and sedative drugs. Do not Have history of allergies to drugs used in the study. Patients should be between 40 and 70 years old. Exclusion criteria: Patients undergoing general anesthesia for any reason after spinal anesthesia.

In the first group, patients in combination with the main drug (bupivacaine); They will receive 10 micrograms of intrathecal dexmedetomidine. In the second group, patients in combination with the main drug (bupivacaine); will receive micrograms of intrathecal sufentanil. In the third group, patients will receive only bupivacaine.

Level and duration of analgesia

Sampling in this study will be that first in order to enter the study patients will be in the form of non-random sampling of the type "available" and then divide them into three intervention groups by randomly assigned blocking using a web-based system. Random blocking at www.randomization.com will be done in 15 blocks of 6. So that in each block, there are 2 people in the first group (A), two people in the second group (B) and two people in the third group (C). After a random sequence was identified in all blocks, cards were written by writing C, B, and A to indicate which group each patient was assigned to, and by someone other than the research team from 1 to 90 in all blocks, respectively. They are numbered and these cards are placed in sealed non-transparent envelopes, respectively. Then, in order to hide the random allocation, when the patient visits, the opaque sealed envelope will be opened and then one by one, it will be determined for each sample of the relevant group.

None of the participants in the study will be aware of the randomization list, and in order to conceal the randomization process, the groups will be placed in closed envelopes in the reception area and will be assigned to the eligible individuals who enter the study. Participants also referred to the type of intervention (drugs in the syringe for injection into the intrathecal space) because the syringes had already been diluted to the same volume; And the position of the patients will not be known during the spinal anesthesia technique. Therefore, the study is double-blind so that patients and the outcome assessment specialist are unaware of the status of the three groups assigned to the study.

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