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: Not yet recruiting
• Conditions: Anxiety; Post Operative Pain; Nausea and Vomiting, Postoperative
• Intervention / Treatment: Other: preoperative IV 0.9% saline 200 ml; Other: preoperative dextrose 5% 200 ml; Other: preoperative and intraoperative dextrose 5% 200 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. 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.

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

Contacts and Locations

• Study Contact: Name: Yusuf Ozguner; Phone Number: +905427150725; Email: y.ozguner@hotmail.com

Study Locations

• Turkey
  • Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle
    • Ankara, Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle, Turkey, 06170
      • Ankara Etlik City Hospital
      • Contact: Yusuf Ozguner; Phone Number: +903127970000; Email: etliksh.iletisim@saglik.gov.tr

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 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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1	Other: preoperative IV 0.9% saline 200 ml; 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	Other: preoperative dextrose 5% 200 ml; Group 2 will be infused with dextrose 5% 400 mL/h for half an hour (200 mL) starting two hours before anesthesia .
Group 3	Other: preoperative and intraoperative dextrose 5% 200 ml; 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 .

What is the study measuring?

Primary 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
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

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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): January 1, 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): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 23, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: laparoscopic cholecystectomy; preoperative intravenous fluid type
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Pain, Postoperative; Nausea; Vomiting; Anxiety Disorders; 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