Comparison of dexmedetomidine and propofol for maintenance anesthesia in cataract surgery

Comparison of dexmedetomidine and propofol for maintaining anesthesia during cataract surgery

The clinical trial has a control group, with parallel groups, double-blind, Random allocation by permutation block method, phase 2 on 60 patients. For randomization, permutation blocks of six will be used.

This study will be conducted on the population of people with cataracts admitted to Heshmatieh Sabzevar Hospital. Patients are randomly assigned into three treatment groups using permutation blocks of six: propofol group, dexmedetomidine, and control group. Routine treatment is considered for the control group. Then, in the first group, dexmedetomidine is added to routine intravenous drugs, and in the second group, propofol is added to routine intravenous drugs. Hemodynamic symptoms (BP, PR, SPO2) are monitored in 5 time periods, including admission to the operating room, before anesthesia, immediately after, 15 minutes later, and during recovery. In addition, blinding is done in a double-blind manner (therapist and the outcome assessor).

obtaining informed consent, At least 60 years old, the absence of other eye diseases؛ the lack of drug sensitivity, the absence of underlying diseases

Three treatment groups include propofol, dexmedetomidine, and a control group

Complications after anesthesia (nausea, dizziness, etc.); the length of time the patient remains in recovery; the amount of receiving narcotic painkillers; incidence and severity of delirium; Duration of patient sedation during cataract surgery

Random allocation will be done by the permutation block method. Blocks of six will be used. In this method, A and B represent the people who receive two interventions and C means the person who is placed in the control group. Considering the block of 6; AABBCC code 0, ABCABC code 1, ABCBAC code 2, BACABC code 3, BBCCAA code 4, and BACBA C code 5. Then, using the table of random numbers, we randomly choose a starting point and consider 10 numbers in a row or column. Therefore, by selecting 10 numbers from the table, it will be determined how to allocate a total of 60 people into 3 groups. Randomization tools are cards marked with three letters A, B, and C. Envelopes will be used to conceal the allocator from the type of card.

Allocation of treatment is done by a person who is unaware of the treatment assigned to all three groups. In this case, cards are provided to the treatment allocator who is not aware of their content. The evaluation of the outcome will be done by a doctor who is not aware of the type of drug-assigned to each group (a doctor other than the treating doctor). In the data analysis, the help of the statistical consultant will be taken, who will not have any information about the type of treatment received by the people. Because during anesthesia, the person is exposed to the drug and is not aware of the type of injected drug, so even though part of the outcome is subjective (measured through VAS), there is no need to blind the patient.

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