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NCT Number: NCT05961722

Preoperative Intravenous Fluid Type and Postoperative Nausea

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Etlik City Hospital

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients who do not accept the study
  • Diabetes Mellitus

Treatment and study plan

preoperative IV 0.9% saline 400 ml

Other

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

preoperative dextrose 5% 400 ml

Other

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

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.

Primary outcomes

  1. PONV Score

    Time frame: 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.

  2. PONV Score

    Time frame: 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.

  3. PONV Score

    Time frame: 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.

  4. PONV Score

    Time frame: 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.

  5. PONV Score

    Time frame: 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.

  6. PONV Score

    Time frame: 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.

Secondary outcomes

  1. Pain on the Numeric Rating Scale (NRS)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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 )

    Time frame: 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 )

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 27, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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