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The Effect of Choosing of Preoperative Intravenous Fluid Type on the Postoperative Nausea, Vomiting, Anxiety and Pain After Laparoscopic Cholecystectomy

Recruiting
Conditions
Post Operative Pain
Anxiety
Nausea and Vomiting, Postoperative
Interventions
Other: preoperative IV 0.9% saline 400 ml
Other: preoperative dextrose 5% 400 ml
Other: preoperative and intraoperative dextrose 5% 400 ml
Registration Number
NCT05961722
Lead Sponsor
Ankara Etlik City Hospital
Brief Summary

In this study, it was aimed to investigate the relationship between postoperative nausea and vomiting, anxiety levels and pain scores in the postoperative period according to dosing and choosing of intravenous fluid type that the patients received in the preoperative period.

Detailed Description

Fluid management is an integral and important part of perioperative treatment. In order to prevent organ damage, a key components of assuring adequate organ perfusion is to provide adequate volume and appropriate fluid. Types of the fluids, amount of the fluid given and timing of the administration are the main topics that determine the fluid management strategy. Colloids (e.g. albumin or fresh frozen plasma (FFP)) and crystalloids (e.g. ringer lactate, isotonic, 5% dextrose) are types of intravenous fluids that are used for fluid replacement apart from blood transfusion . Crystalloids are low-cost salt solutions with small molecules, which can move around easily when injected into the body.

There are studies reporting that fluid therapy applied in the preoperative period reduces gastric acid secretion and reduces stomach movements and nausea and vomiting. In addition, there are studies reporting that fluids given in the preoperative period have a positive effect on anxiety levels by reducing the feeling of hunger and thirst in patients. There are studies reporting that fluid therapy reduces ATP destruction and oxidative stress, which contributes to the reduction of pain levels.

90 ASA I-II patients who will undergo laparoscopic cholecystectomy surgery will be included in the study and will be divided into three equal groups. Group 1 will be infused with IV 0.9% saline 400 mL/h for half an hour (200 mL) starting two hours before anesthesia. Group 2 will be infused with dextrose 5% 400 mL/h for half an hour (200 mL) starting two hours before anesthesia . Group 3 will be infused with dextrose 5% 400 mL/h for half an hour (200 mL) starting two hours before anesthesia and with dextrose 5% 400 mL/h for half an hour (200 mL) during surgery . Intraoperative IV 0.9% saline infusion at a rate of 10 ml/kg/h will be administered to patients in all groups.

Postoperative nausea and vomiting (PONV) , within 24 hours was compared between groups by PONV score. Other outcomes were the antiemetic drugs needed, The NRS Score, The State-Trait Anxiety Inventory , additional analgesic drug requirement.

In this study, it was aimed to investigate the relationship between postoperative nausea and vomiting, anxiety levels and pain scores in the postoperative period according to dosing and choosing of intravenous fluid type that the patients received in the preoperative period.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
90
Inclusion Criteria
  • Patients who underwent laparoscopic cholecystectomy between August 1, 2023 and November 1, 2023
  • Patients over the age of 18
Exclusion Criteria
  • Patients who do not accept the study
  • Diabetes Mellitus

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Group 1preoperative IV 0.9% saline 400 mlGroup receiving preoperative and intraoperative saline infusion.
Group 2preoperative dextrose 5% 400 mlThe group receiving preoperative dextrose and intraoperative saline infusion.
Group 3preoperative and intraoperative dextrose 5% 400 mlThe group receiving preoperative and intraoperative dextrose infusion.
Primary Outcome Measures
NameTimeMethod
PONV Score24 hours postoperatively

Postoperative nausea and vomitting recording in patients undergone laparoscopic cholocystectomy.

* 0=no PONV: patient reports no nausea and has had no emesis episodes;

* 1=mild PONV: patient reports nausea but declines antiemetic treatment;

* 2=moderate PONV: patient reports nausea and accepts antiemetic treatment; and

* 3=severe PONV: nausea with any emesis episode (retching or vomiting). Higher scores indicate severe postoperative nausea and vomitting.

Secondary Outcome Measures
NameTimeMethod
Pain on the Numeric Rating Scale (NRS)24 hours postoperatively

Participants recorded pain rated on the numeric rating scale (NRS) at 6 time points. NRS range was from 0-10 with 0 being no pain and 10 the worst pain possible.

State-Trait Anxiety Inventory ( The STAI )0 hours postoperatively

The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. It has 20 items for assessing trait anxiety and 20 for state anxiety. All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always"). Higher scores indicate greater anxiety.

Trial Locations

Locations (1)

Ankara Etlik City Hospital

🇹🇷

Ankara, Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle, Turkey

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