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Clinical Trials/NCT05752734
NCT05752734CompletedNot Applicable

Preoperative Dexamethasone Enhances Quality of Recovery After Laparoscopic Bariatric Surgery: A Prospective Observational Study

Ondokuz Mayıs University1 site in 1 country60 target enrollmentStarted: February 2, 2023Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Global Quality of Recovery (QoR-40) score in the first 24 hours after surgery

Study Overview

Brief Summary

In the obese patient, adequate pain relief in the postoperative period is an important parameter that affects patient comfort and hospital stay. Increasing patient comfort and recovery quality can be achieved by avoiding undesirable effects such as nausea and vomiting, as well as analgesia. In our study, our aim is to evaluate the effect of dexamethasone added to multimodal analgesia on postoperative patient comfort in the obese patient group with a 40-item scale.

Detailed Description

Postoperative pain prolongs hospital stay, delays wound healing, increases infection rates, and increases the incidence of drug side effects due to the use of systemic pain relievers (especially opioids).

Good pain control facilitates respiratory effort, allows the patient to perform respiratory exercises and cough to correct the increased thoracic fat mass and impaired respiratory mechanics due to anesthesia. The patient without pain is mobilized early and discharged early.

Our aim is to evaluate the effect of dexamethasone added to multimodal analgesia on postoperative patient comfort in the obese patient group with a 40-item scale.

Patients will be divided in to two groups (group D and group C):

Group D (Dexamethasone Group):

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Body mass index>30 kg/m2
  • The American Society of Anaesthesiologists (ASA) physical status class I, II
  • The American Society of Anaesthesiologists (ASA) physical status class III only because of morbid obesity
  • Patients who will undergo an elective laparoscopic sleeve gastrectomy (LSG)
  • Those who are literate enough to answer the compilation quality score (QoR-40) questionnaire

Exclusion Criteria

  • refusal to participate
  • allergy to the study drugs
  • chronic kidney disease (creatinine>150 μmol/L)
  • mental illness
  • liver, respiratory or oncological disease,
  • cardiac dysfunction (ejection fraction <40%),
  • uncontrolled hypertension,
  • preoperative analgesic use,
  • chronic pain,
  • history of alcohol or drug addiction

Arms & Interventions

Group D

Patients who used/applied dexamethasone before bariatric surgery were included in this group.

Intervention: Group D (Drug)

Group C

Patients who did not use dexamethasone or steroid-derived drugs were included in this group.

Intervention: Group C (Drug)

Outcomes

Primary Outcomes

Global Quality of Recovery (QoR-40) score in the first 24 hours after surgery

Time Frame: postoperative day 1

The recovery quality of the patients 24 hours after the operation will be evaluated with the QoR-40 questionnaire. The questionnaire consists of 40 questions that examine five domains of patient recovery using a five point Likert scale: none of the time, some of the time, usually, most of the time, and all of the time. The five domains include physical comfort, pain, physical independence, psychological support, and emotional state. As a result of the evaluation, the total score ranges from 40 (worst review quality score) to 200 (best review quality score).

The score for each of the five parameters that make up the QoR-40 questionnaire

Time Frame: postoperative day 1

It consists of 5 parameters: physical independence score (n = 5), patient support score (n = 7), Physical comfort score (n = 12), emotional state score (n = 9) and pain score (n = 7).

Secondary Outcomes

  • Morphine consumption in the first 24 hours after surgery(postoperative day 1)
  • The incidences of post-operative nausea and vomiting (PONV)(postoperative day 1)
  • Time to first mobilization(Up to 24 hours after surgery.)
  • Time to discharge(Trough hospital stay, an average of 1 week)

Investigators

Sponsor
Ondokuz Mayıs University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yasemin Burcu Ustun

Professor

Ondokuz Mayıs University

Study Sites (1)

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