Preoperative Intravenous Fluid Type and Postoperative Nausea

NCT ID: NCT05961722

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-08-05

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.

Conditions

Post Operative Pain; Nausea and Vomiting, Postoperative; Anxiety

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

Group receiving preoperative and intraoperative saline infusion.

preoperative IV 0.9% saline 400 ml

Intervention Type: OTHER

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

Group 2

The group receiving preoperative dextrose and intraoperative saline infusion.

preoperative dextrose 5% 400 ml

Intervention Type: OTHER

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

Group 3

The group receiving preoperative and intraoperative dextrose infusion.

preoperative and intraoperative dextrose 5% 400 ml

Intervention Type: OTHER

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

Interventions

preoperative IV 0.9% saline 400 ml

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

Intervention Type: OTHER

preoperative dextrose 5% 400 ml

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

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara Etlik City Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Yusuf Özgüner

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara Etlik City Hospital

Ankara, Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: RESULT

PMID: 27900717 (View on PubMed)

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.

Reference Type: RESULT

PMID: 16288616 (View on PubMed)

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.

Reference Type: RESULT

PMID: 11682427 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30188590 (View on PubMed)

Other Identifiers

AnkaraEtlikYusufOzguner003

Identifier Type: -

Identifier Source: org_study_id