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

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

This randomized and double-blind clinical trial with parallel and control groups will be conducted on 140 patients who will be randomly selected using the random number table.

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.

Inclusion criteria: 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. Exclusion criteria: 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.

The intervention group will receive midazolam, fentanyl and propofol to induce anesthesia, then will receive one third of fluid maintenance during surgery. The control group will receive midazolam, fentanyl and propofol to induce anesthesia, then will receive standard rate of fluid maintenance during surgery.

Evaluation the total fluid rate injection during intraoperative, duration of anesthesia, duration of hospitalization, pulmonary complications and mortality rate.

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.

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.

The research data obtained from the main outcomes of the study can be shared freely as 'open data'.

6 months after publishing the results

The research data is exclusively accessible to the researchers working at universities and centers for scientific research.

The research data is exclusively accessible to the researchers working at universities and centers for scientific research.

Mandana Jahanian provides the data analysis to the applicants via email: jahanianm991@mums.ac.ir

Applicants can send emails to him and receive a response within a week.