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IRCT20241021063443N1 IRCT 2024-12-23 Mashhad University of Medical Sciences The effect of lidocaine on quality of postoperative sleep The effect of intraoperative lidocaine infusion compared to placebo on postoperative sleep quality in patients undergoing surgery for right lung hydatid cyst 2025-01-20 anticipated 36 Complete https://irct.ir/trial/79707 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Based on the sequence generated by the www.randomizatiom.ir, patients will be randomly assigned to one of two lidocaine or normal saline groups with a ratio of 1:1. Sequential numbers from 1 to 70 will be marked on envelope for each person. 35 sheets of paper marked L (lidocaine group) and 35 sheets marked N (normal saline group) will be sealed inside the envelopes. During the study, the technician opens the envelope and prepares the drugs according to the group specified in the L or N sheet. Normal saline will be exactly the same as lidocaine in terms of color, smell, volume and administration method, Blinding description: The patients, the anesthetist who administers the drug, and the assistant who collects the data, as well as the person who will analyze the data, will be blinded to the study groups. The protocol and objectives of the study are explained to the patient, and after consent to participate in the study, the nurse prepares the medications according to the order of the prepared packets. Therefore, only the nurse knows whether the patient received lidocaine or placebo. Normal saline is considered a placebo, which is similar in appearance and smell to lidocaine. Therefore, the patient (due to lack of consciousness), the anesthesiologist and assistant who collects information after the operation, as well as the person who analyzes, have no information about the receipt of lidocaine or placebo. 3 Right lung hydatid cyst. Intervention 1: Intervention group: Continuous infusion of 2 mg/kg/hour of 2% lidocaine ampoule (100 mg in 5cc) produced by Caspian Company during surgery using an JMS Syringe pump SP-500. Intervention 2: Control group: Continuous infusion of 2 mg per kg per hour normal saline during the surgery using an infusion pump -model SP500-JMS. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Shabnam Niroumand
No 22, South Bozorgmehr 13, Sajjad Blvd
Mashhad Iran (Islamic Republic of) 918661865 +98 51 3841 2081 niroumandsh@mums.ac.ir Mashhad University of Medical Sciences scientific Shabnam Niroumand
No 22, South Bozorgmehr 13, Sajjad Blvd
Mashhad Iran (Islamic Republic of) 918661365 +98 51 3841 2081 niroumandsh@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients who are candidates for lung hydatid cyst surgery Patients aged 18-50 years 18 years 50 years Both leep disorder before entering the study (in the patient's self-report or the anesthesiologist's examination) Taking sleeping pills before entering the study Having a history of addiction B67 Echinococcosis Rehabilitation Rehabilitation Intervention group: Continuous infusion of 2 mg/kg/hour of 2% lidocaine ampoule (100 mg in 5cc) produced by Caspian Company during surgery using an JMS Syringe pump SP-500 Control group: Continuous infusion of 2 mg per kg per hour normal saline during the surgery using an infusion pump -model SP500-JMS Sleep quality after surgery based on Pittsburgh Sleep Quality Index (PSQI) score. Timepoint: Determining Sleep quality before surgery and day 1 and 3 after surgery. Method of measurement: Using the Pittsburgh Sleep Quality Index (PSQI) questionnaire. The dose of remifentanil used during the operation. Timepoint: Immediately after surgery. Method of measurement: Measuring the dose of remifentanil used during anesthesia,. The presence of cough within 5 minutes after the ex-tube and also the cough scores. Timepoint: Immediately after surgery. Method of measurement: Based on the 4-point Minogue scale. The score of pain after the operation. Timepoint: Immediately after surgery. Method of measurement: Based on Visual Analog Scale. The occurrence of nausea and vomiting after the operation. Timepoint: Immediately after surgery. Method of measurement: Based on self expression and observation. Mashhad University of Medical Sciences Approved 2024-08-05 Ethics committee of Imam Reza Hospital, Mashhad University of Medical Sciences Faculty of Medicine, Mashhad University of Medical Sciences, Azadi Square, Mashhad, Khorasan Razavi Province, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)