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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Post Operative Pain, Nausea and Vomiting, Postoperative, Anxiety

Intervention / Treatment
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* Other: preoperative IV 0.9% saline 200 ml
* Other: preoperative dextrose 5% 200 ml
* Other: preoperative and intraoperative dextrose 5% 200 ml


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Other: preoperative IV 0.9% saline 200 ml<br>* Group 1 will be infused with IV 0.9% saline 400 mL/h for half an hour (200 mL) starting two hours before anesthesia.<br>|
| Group 2<br> | Other: preoperative dextrose 5% 200 ml<br>* Group 2 will be infused with dextrose 5% 400 mL/h for half an hour (200 mL) starting two hours before anesthesia .<br>|
| Group 3<br> | Other: preoperative and intraoperative dextrose 5% 200 ml<br>* 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 .<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preoperative intravenous fluid type, laparoscopic cholecystectomy