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IRCT20221116056524N1 IRCT 2023-06-24 Tabriz University of Medical Sciences The effect of dexmedetomidine infusion on the treatment of intraoperative shoulder pain The effect of dexmedetomidine infusion on the treatment of intraoperative shoulder pain in diagnostic laparoscopic gynecological procedures under spinal anesthesia 2023-03-21 anticipated 70 Complete https://irct.ir/trial/66923 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: 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, Blinding description: 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. 3 The effect of dexmedetomidine infusion on the treatment of intraoperative shoulder pain. Intervention 1: Intervention group:In 35 women, before entering the operating room and after initial monitoring and before spinal anesthesia, intravenous bolus dexmedetomidine 1μg/kg was injected within ten minutes and then the infusion of dexmedetomidine 0.5μg/kg/h was started and its effect on pain The shoulder will be checked. Intervention 2: Control group: In 35 women, before spinal anesthesia, upon entering the operating room and after initial monitoring, one milliliter of sodium chloride 0.90% was injected intravenously as a placebo and its effect on shoulder pain will be investigated. Yes - There is a plan to make this available What will be shared: All potential data can be shared after making peoples unrecognizable. When: Starting 6 months after publication To whom: Documents will be available for people working in academic institutions and also people working in businesses Conditions: There will be no specific limitations to the utilization of the data Where to obtain: 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 How to obtain: Applicants will access the data from the present study by sending an email to the responsible author for a maximum of one week Comments:
public Reyhaneh abri
Department of anesthesiology, alzahra hospital, south artesh street
Tabriz Iran (Islamic Republic of) 5174815811 +98 41 3553 9163 reyhaneh.abri@gmail.com Tabriz University of Medical Sciences scientific Reyhaneh abri
Department of anesthesiology, alzahra hospital, south artesh street
Tabriz Iran (Islamic Republic of) 5174815811 +98 41 3553 9163 reyhaneh.abri@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Female with physical status ASA class I.II, candidate for diagnostic laparoscopic surgery for women in the age range of 18-60 years in Al-Zahra Hospital, Tabriz Patient consent to enter the study 18 years 60 years Female Presence of any regional anesthesia contraindications, sensitivity to local anesthetics and dexmedetomidine excessive obesity Associated systemic diseases such as any history of cardiovascular, pulmonary, liver, kidney and etc. Patient dissatisfaction Treatment - Drugs Placebo Intervention group:In 35 women, before entering the operating room and after initial monitoring and before spinal anesthesia, intravenous bolus dexmedetomidine 1μg/kg was injected within ten minutes and then the infusion of dexmedetomidine 0.5μg/kg/h was started and its effect on pain The shoulder will be checked. Control group: In 35 women, before spinal anesthesia, upon entering the operating room and after initial monitoring, one milliliter of sodium chloride 0.90% was injected intravenously as a placebo and its effect on shoulder pain will be investigated. Intraoperative shoulder pain in women's diagnostic laparoscopic surgeries. Timepoint: The severity of shoulder and abdominal pain, based on Visual Analogue Scale score and degree of sedation according to Ramsay sedation score, is recorded every 15 minutes until the patient's full recovery and delivery to the ward, and in case of Visual Analogue Scale scores higher than 3, the patient's pain will be treated with painkillers. The dosage of additional drugs will also be recorded. Method of measurement: Based on Visual Analogue Scale score and Grade Sedation with Ramsay sedation score. TABRIZ UNIVERSITY OF MEDICAL SCIENCES Approved 2022-05-11 Ethics Committee of Tabriz University of Medical Sciences Department of anesthesiology, alzahra hospital, south artesh street Tabriz East Azarbaijan Iran (Islamic Republic of)