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IRCT20220627055294N1 IRCT 2022-06-30 Mashhad University of Medical Sciences The effectiveness of the amount of intraoperative fluid administration on pulmonary complications after lobectomy of left lung A clinical trial to compare the effectiveness of administration of the one third of intraoperative fluid with standard amount of fluid on pulmonary complications after lobectomy of left lung 2022-08-23 anticipated 140 Complete https://irct.ir/trial/64489 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, simple randomization will be used by random number table based on SAS (statistical analysis system), software. A list of sequentially number 1 to 10 will be created. This list will assign numbers randomly by computer. Patients are randomly assigned according to the numbers of this list. To conceal, we use allocation concealment, using non-transparent envelopes sealed with random sequences (Sequentially numbered, sealed, opaque envelopes). They are placed in order. In order to maintain the random sequence, numbering is done on the outer surface of the envelopes in the same way. Finally, the lids of the envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants in the study, one of the envelopes will be opened in order and the assigned group of the participant will be revealed, Blinding description: Patients candidate for lobectomy of left lung referring to Ghaem Hospital, Mashhad, Iran are chosen as the participants of the study. In this double-blind study, sealed opaque envelopes will be used to conceal the sequencing. Intervention group will receive the one third of intraoperative fluid and control will receive standard amount of fluids. The participants and responsible for data collection are blind to group allocation and the type of intervention. 2-3 Pulmonary complications after lobectomy. Intervention 1: Intervention group: The intervention group will receive midazolam, fentanyl and propofol to induce anesthesia, then will receive one third of fluid maintenance during surgery. Intervention 2: Control group: The control group will receive midazolam, fentanyl and propofol to induce anesthesia, then will receive standard rate of fluid maintenance during surgery. Yes - There is a plan to make this available What will be shared: The research data obtained from the main outcomes of the study can be shared freely as 'open data'. When: 6 months after publishing the results To whom: The research data is exclusively accessible to the researchers working at universities and centers for scientific research. Conditions: The research data is exclusively accessible to the researchers working at universities and centers for scientific research. Where to obtain: Mandana Jahanian provides the data analysis to the applicants via email: jahanianm991@mums.ac.ir How to obtain: Applicants can send emails to him and receive a response within a week. Comments:
public Mandana Jahanian
Ghaem Hospital, Ahmadabad Street, Dr. Ali Shariati Square
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3840 0000 jahanianm991@mums.ac.ir Mashhad University of Medical Sciences scientific Mandana Jahanian
Ghaem Hospital, Ahmadabad Street, Dr. Ali Shariati Square
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3840 0000 jahanianm991@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients with ASA I, II or III, who are candidate for lobectomy of left lung Not having cardiovascular disease Not having kidney failure Not having systemic disease such as diabetes, hypertension and thyroid disease no limit no limit Both Receiving high intraoperative blood transfusion volume greater than 50 percent of the total blood volume of patient during three hours Receiving diuretics and osmotic substances before surgery Patient cardiopulmonary arrest J95.3 Chronic pulmonary insufficiency following surgery Prevention Prevention Intervention group: The intervention group will receive midazolam, fentanyl and propofol to induce anesthesia, then will receive one third of fluid maintenance during surgery. Control group: The control group will receive midazolam, fentanyl and propofol to induce anesthesia, then will receive standard rate of fluid maintenance during surgery. The total fluid rate injection during intraoperative. Timepoint: During surgery. Method of measurement: Total volume of injected fluids in cc per kg. Duration of anesthesia. Timepoint: After intervention. Method of measurement: The number of hours of postoperative anesthesia. The duration of hospitalization. Timepoint: Two weeks after intervention. Method of measurement: The number days of hospitalization. Pulmonary complications (acute respiratory distress syndrome, intubation, atelectasis, pneumonia, persistent air leaks). Timepoint: 48 hours after intervention. Method of measurement: Based on clinical examinations. Mortality rate. Timepoint: 48 hours after intervention. Method of measurement: Calculating a mortality rate. Mashhad University of Medical Sciences Approved 2022-05-31 Ethics Committee of Mashhad University of Medical Sciences Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)