Preoperative Intravenous Fluid Type and Postoperative Nausea

NCT05961722 | Completed

• 1 other identifier: AnkaraEtlikYusufOzguner003
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain; Anxiety; Nausea and Vomiting, Postoperative

Keywords

preoperative intravenous fluid type; laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (8)

• Pain on the Numeric Rating Scale (NRS)

  0 hours postoperatively

• Pain on the Numeric Rating Scale (NRS)

  2 hours postoperatively

• Pain on the Numeric Rating Scale (NRS)

  4 hours postoperatively

• Pain on the Numeric Rating Scale (NRS)

  8 hours postoperatively

• Pain on the Numeric Rating Scale (NRS)

  12 hours postoperatively

Study Arms (3)

Group 1

Group receiving preoperative and intraoperative saline infusion.

Other: preoperative IV 0.9% saline 400 ml

Group 2

The group receiving preoperative dextrose and intraoperative saline infusion.

Other: preoperative dextrose 5% 400 ml

Group 3

The group receiving preoperative and intraoperative dextrose infusion.

Other: preoperative and intraoperative dextrose 5% 400 ml

Interventions

preoperative IV 0.9% saline 400 ml OTHER

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

Group 1

preoperative dextrose 5% 400 ml OTHER

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

Group 2

preoperative and intraoperative dextrose 5% 400 ml OTHER

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

Group 3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Patients who do not accept the study
• Diabetes Mellitus

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle, 06170, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 27900717 RESULT

• 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.

  PMID: 16288616 RESULT

• 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.

  PMID: 11682427 RESULT

• 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.

  PMID: 30188590 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting; Anxiety Disorders

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting; Mental Disorders

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: July 27, 2023
• Study Start: October 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: August 5, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)