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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05961722
• Other study ID #: AnkaraEtlikYusufOzguner003
• Status: Not yet recruiting
• Start date: August 1, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: July 2023
• Source: Ankara Etlik City Hospital
• Contact: Yusuf Ozguner
• Phone: +905427150725
• Email: y.ozguner[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: January 1, 2024
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Nausea
• Nausea and Vomiting, Postoperative
• Pain, Postoperative
• Post Operative Pain
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

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.
• 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 .
• 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 .

Locations

Country	Name	City	State
Turkey	Ankara Etlik City Hospital	Ankara	Varlik Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Etlik City Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View Citation

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: 10.1097/00000 — View Citation

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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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