Clinical trial NCT05961722: Preoperative Intravenous Fluid Type and Postoperative Nausea
Official title: The Effect of Choosing of Preoperative Intravenous Fluid Type on the Postoperative Nausea, Vomiting, Anxiety and Pain After Laparoscopic Cholecystectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Operative Pain
Nausea and Vomiting, Postoperative
Anxiety
Keywords: preoperative intravenous fluid type
laparoscopic cholecystectomy
Lead sponsor: Ankara Etlik City Hospital
Sponsor class: OTHER_GOV
First posted: 2023-07-27
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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. Patients in Group 1 were administered 400 ml 0.9% saline infusion within 30 minutes, 2 hours before surgery. Patients in Group 2 were infused with 400 ml 5% Dextrose at the same infusion rate. In groups 1 and 2, 10 ml/kg/h 0.9% saline infusion was applied during the intraoperative period. Patients in Group 3 were administered 200 ml dextrose infusion in the preoperative period and 200 ml dextrose infusion in the intraoperative period. 0.9% saline infusion was applied so that the total intraoperative fluid volume was the same as in the other 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.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent laparoscopic cholecystectomy
* Patients over the age of 18

Exclusion Criteria:

* Patients who do not accept the study
* Diabetes Mellitus

Primary outcomes:
measure: PONV Score
timeFrame: 0 hours postoperatively
measure: PONV Score
timeFrame: 2 hours postoperatively
measure: PONV Score
timeFrame: 4 hours postoperatively
measure: PONV Score
timeFrame: 8 hours postoperatively
measure: PONV Score
timeFrame: 12 hours postoperatively
measure: PONV Score
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Pain on the Numeric Rating Scale (NRS)
timeFrame: 0 hours postoperatively
measure: Pain on the Numeric Rating Scale (NRS)
timeFrame: 2 hours postoperatively
measure: Pain on the Numeric Rating Scale (NRS)
timeFrame: 4 hours postoperatively
measure: Pain on the Numeric Rating Scale (NRS)
timeFrame: 8 hours postoperatively
measure: Pain on the Numeric Rating Scale (NRS)
timeFrame: 12 hours postoperatively
measure: Pain on the Numeric Rating Scale (NRS)
timeFrame: 24 hours postoperatively
measure: State-Trait Anxiety Inventory ( The STAI )
timeFrame: 2 hours before induction of anesthesia
measure: State-Trait Anxiety Inventory ( The STAI )
timeFrame: 0 hours postoperatively
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
state: Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle
Study officials:
References:
citation: Hoorn EJ. Intravenous fluids: balancing solutions. J Nephrol. 2017 Aug;30(4):485-492. doi: 10.1007/s40620-016-0363-9. Epub 2016 Nov 29.
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citation: Hausel J, Nygren J, Lagerkranser M, Hellstrom PM, Hammarqvist F, Almstrom C, Lindh A, Thorell A, Ljungqvist O. A carbohydrate-rich drink reduces preoperative discomfort in elective surgery patients. Anesth Analg. 2001 Nov;93(5):1344-50. doi: 10.1097/00000539-200111000-00063.
citation: Kristoffersen L, Malahleha M, Duze Z, Tegnander E, Kapongo N, Stoen R, Follestad T, Eik-Nes SH, Bergseng H. Randomised controlled trial showed that neonates received better pain relief from a higher dose of sucrose during venepuncture. Acta Paediatr. 2018 Dec;107(12):2071-2078. doi: 10.1111/apa.14567. Epub 2018 Oct 2.