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

Sponsor
Ankara Etlik City Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05961722
Collaborator
(none)
90
1
5
17.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
90 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
The Effect of Choosing of Preoperative Intravenous Fluid Type on the Postoperative Nausea, Vomiting, Anxiety and Pain After Laparoscopic Cholecystectomy
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm 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 .

Outcome Measures

Primary Outcome Measures

  1. Pain on the Numeric Rating Scale (NRS) [0 hours postoperatively]

    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. Pain on the Numeric Rating Scale (NRS) [2 hours postoperatively]

    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.

  3. Pain on the Numeric Rating Scale (NRS) [4 hours postoperatively]

    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. Pain on the Numeric Rating Scale (NRS) [8 hours postoperatively]

    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.

  5. Pain on the Numeric Rating Scale (NRS) [12 hours postoperatively]

    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.

  6. Pain on the Numeric Rating Scale (NRS) [24 hours postoperatively]

    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.

  7. State-Trait Anxiety Inventory ( The STAI ) [2 hours before induction of anesthesia]

    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.

  8. State-Trait Anxiety Inventory ( The STAI ) [0 hours postoperatively]

    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.

  9. PONV Score [0 hours postoperatively]

    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.

  10. PONV Score [2 hours postoperatively]

    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.

  11. PONV Score [4 hours postoperatively]

    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. PONV Score [8 hours postoperatively]

    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.

  13. PONV Score [12 hours postoperatively]

    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.

  14. PONV Score [24 hours postoperatively]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ankara Etlik City Hospital Ankara Varlık Mahallesi, Halil Sezai Erkut Caddesi Yenimahalle Turkey 06170

Sponsors and Collaborators

  • Ankara Etlik City Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yusuf Özgüner, Principal Investigator, Ankara Etlik City Hospital
ClinicalTrials.gov Identifier:
NCT05961722
Other Study ID Numbers:
  • AnkaraEtlikYusufOzguner003
First Posted:
Jul 27, 2023
Last Update Posted:
Jul 27, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yusuf Özgüner, Principal Investigator, Ankara Etlik City Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2023