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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety; Post Operative Pain; Nausea and Vomiting, Postoperative
• Intervention / Treatment: Other: preoperative IV 0.9% saline 400 ml; Other: preoperative dextrose 5% 400 ml; Other: preoperative and intraoperative dextrose 5% 400 ml

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.

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Turkey
  • Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle
    • Ankara, Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle, Turkey, 06170
      • Ankara Etlik City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patients who do not accept the study
• Diabetes Mellitus

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Group receiving preoperative and intraoperative saline infusion.	Other: preoperative IV 0.9% saline 400 ml; Group 1 will be infused with IV 0.9% saline 400 mL.
Group 2; The group receiving preoperative dextrose and intraoperative saline infusion.	Other: preoperative dextrose 5% 400 ml; Group 2 will be infused with dextrose 5% Dekstroz 400 ml.
Group 3; The group receiving preoperative and intraoperative dextrose infusion.	Other: preoperative and intraoperative dextrose 5% 400 ml; Group 3 will be infused with dextrose preoperative 200 ml and intraoperative 200 ml 5% dextrose infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PONV Score	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.	0 hours postoperatively
PONV Score	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.	2 hours postoperatively
PONV Score	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.	4 hours postoperatively
PONV Score	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.	8 hours postoperatively
PONV Score	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.	12 hours postoperatively
PONV Score	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.	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain on the Numeric Rating Scale (NRS)	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.	0 hours postoperatively
Pain on the Numeric Rating Scale (NRS)	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.	2 hours postoperatively
Pain on the Numeric Rating Scale (NRS)	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.	4 hours postoperatively
Pain on the Numeric Rating Scale (NRS)	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.	8 hours postoperatively
Pain on the Numeric Rating Scale (NRS)	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.	12 hours postoperatively
Pain on the Numeric Rating Scale (NRS)	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.	24 hours postoperatively
State-Trait Anxiety Inventory ( The STAI )	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.	2 hours before induction of anesthesia
State-Trait Anxiety Inventory ( The STAI )	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.	0 hours postoperatively

Collaborators and Investigators

• Sponsor: Ankara Etlik City Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• Agarwal A, Dhiraaj S, Tandon M, Singh PK, Singh U, Pawar S. Evaluation of capsaicin ointment at the Korean hand acupressure point K-D2 for prevention of postoperative nausea and vomiting. Anaesthesia. 2005 Dec;60(12):1185-8. doi: 10.1111/j.1365-2044.2005.04402.x.
• 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. Erratum In: J Nephrol. 2020 Apr;33(2):387. doi: 10.1007/s40620-020-00704-5.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): August 5, 2024

Study Registration Dates

• First Submitted: July 13, 2023
• First Submitted That Met QC Criteria: July 23, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: laparoscopic cholecystectomy; preoperative intravenous fluid type
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Pain, Postoperative; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: AnkaraEtlikYusufOzguner003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No