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Preoperative Intravenous Fluid Type and Postoperative Nausea

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05961722
Enrollment
90
Registered
2023-07-27
Start date
2023-10-01
Completion date
2024-08-05
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Nausea and Vomiting, Postoperative, Post Operative Pain

Keywords

preoperative intravenous fluid type, laparoscopic cholecystectomy

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.

Interventions

OTHERpreoperative IV 0.9% saline 400 ml

Group 1 will be infused with IV 0.9% saline 400 mL.

OTHERpreoperative dextrose 5% 400 ml

Group 2 will be infused with dextrose 5% Dekstroz 400 ml.

OTHERpreoperative and intraoperative dextrose 5% 400 ml

Group 3 will be infused with dextrose preoperative 200 ml and intraoperative 200 ml 5% dextrose infusion.

Sponsors

Ankara Etlik City Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Patients who do not accept the study * Diabetes Mellitus

Design outcomes

Primary

MeasureTime frameDescription
PONV Score0 hours postoperativelyPostoperative 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

MeasureTime frameDescription
Pain on the Numeric Rating Scale (NRS)0 hours postoperativelyParticipants 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 )2 hours before induction of anesthesiaThe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026