The effect of dexmedetomidine infusion on the treatment of intraoperative shoulder pain in diagnostic laparoscopic gynecological procedures under spinal anesthesia

Investigating the effect of intravenous infusion of dexmedetomidine on the treatment of intraoperative shoulder pain in diagnostic laparoscopic surgeries of women with spinal anesthesia

Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 70 patients. Using the online software available at www.start.vbc.ca/nrolin/statssize/bz.htmf, patients will be entered into one of two groups of 35 people.

In Tabriz alzahra hospital in 1402, the effect of dexmedetomidine injection on shoulder pain in diagnostic laparoscopic surgery will be evaluated in randomly assigned to intervention and placebo groups. Patients and data recorders will be blinded to the study

-Female with physical status II or ASA class I, candidate for diagnostic laparoscopic surgery for women in the age range of 18-60 years. -Patient consent to enter the study. Criteria for not entering the study: -The presence of any regional anesthesia contraindications. -Hypersensitivity to local anesthetics and dexmedetomidine. -excessive obesity. -Associated systemic diseases such as any history of cardiovascular, pulmonary, liver, kidney disease ande ... -Patient dissatisfaction.

The effect of dexmedetomidine on shoulder pain in diagnostic laparoscopic surgery group intervention (n=35)and the control group (placbo)(n=35) would be compared

All study data will be collected through a questionnaire prepared for this purpose and will be analyzed using SPSS24 statistical software.

This study will be a prospective and randomized double-blind clinical trial, after obtaining the approval of the ethical committee and obtaining written informed consent from the patient, a number of 70 women aged 18-60 years with physical status ASA I, II (American Society of Anesthesiologists), female that candidates for diagnostic laparoscopic surgery will be randomly divided into two groups. By using the online software available at www.start.vbc.ca/nrolin/statssize/bz.htmf, patients will be entered into one of two groups of 35 people.

In group A patients, before spinal anesthesia, intravenous bolus dexmedetomidine 1μg/kg was injected within ten minutes and then the infusion of dexmedetomidine 0.5 μg/kg/h was started, and in group B patients, infusion with the same volume and dose of 0.9 % sodium chloride serum was started as placebo by the anesthesiologist in charge of the procedure and will be continue until the patient is delivered to the PACU.All the operations will be performed by respected female surgeons who are at the same level of skill and experience. Vital signs of the patient including blood pressure, heart rate, SPO2, RR and ETCO2 upon entering the operating room, after dexmedetomidine bolus injection, before spinal anesthesia, after spinal anesthesia, before pneumoperitoneum, during pneumoperitoneum, after  Trendelenberg positioning, then it will be recorded every 5 minutes until the end of the procedure and after emptying the intra-abdominal gas and transferring the patient to the PACU. Also, the severity of shoulder or abdominal pain, based on VAS score and degree of sedation according to Ramsay sedation score (with the aim of maintaining a score of 2-3) will be recorded every 10 minutes until the end of surgery and in the PACU.Also, other side effects (respiratory depression, difficulty breathing, nausea and vomiting, chills, itching) will also be recorded and treated. Possible complications during surgery such as hypertension ,hypotension, bradycardia is recorded in all of the patients, and Also, the severity of shoulder or abdominal pain, based on VAS score and degree of sedation according to Ramsay sedation score (with the aim of maintaining a score of 2-3) will be recorded every 10 minutes until the end of surgery and in the PACU.Also, other complications (respiratory depression, difficulty breathing, nausea and vomiting, chills, itching) will also be recorded and treated. The duration of surgery and anesthesia and the time between the delivery of the patient in the PACU and obtaining full recovery parameters and the possibility of delivery to the ward will be recorded in both groups. Also, the satisfaction of the patient and the surgeon (in the form of non-satisfaction, moderate satisfaction, complete satisfaction) will also be recorded at the end of the surgery.

All potential data can be shared after making peoples unrecognizable.

Starting 6 months after publication

Documents will be available for people working in academic institutions and also people working in businesses

There will be no specific limitations to the utilization of the data

Dr .Reyhaneh Abri, Department of Anesthesiology, Faculty of Medicine, Golgasht Street, Tabriz East Azarbaijan Islamic Republic of Iran ,Phone+98 413 3341994, Fax+98 41 33341994 , re.abri@tbzmed.ac.ir

Applicants will access the data from the present study by sending an email to the responsible author for a maximum of one week