Clinical trial NCT05752734: Preoperative Dexamethasone to Improve Quality of Recovery After Laparoscopic Bariatric Surgery
Official title: Preoperative Dexamethasone Enhances Quality of Recovery After Laparoscopic Bariatric Surgery: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Analgesia
Acute Pain
Keywords: dexamethasone
quality of recovery-40
acute pain scores
morphine consumption
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2023-03-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with BMI \> 30 undergoing elective laparoscopic sleeve gastrectomy (LSG)

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):

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

Group C(Control Group):

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

The patients included in the study were evaluated with the 40-item recovery quality scale (QoR-40) 24 hours after the operation.

İn addition all patients will be administered iv morphine pca (patient controlled analgesia) for the first 24 hours postoperatively

Eligibility criteria: 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

Primary outcomes:
measure: Global Quality of Recovery (QoR-40) score in the first 24 hours after surgery
timeFrame: postoperative day 1
measure: The score for each of the five parameters that make up the QoR-40 questionnaire
timeFrame: postoperative day 1
Secondary outcomes:
measure: Morphine consumption in the first 24 hours after surgery
timeFrame: postoperative day 1
measure: The incidences of post-operative nausea and vomiting (PONV)
timeFrame: postoperative day 1
measure: Time to first mobilization
timeFrame: Up to 24 hours after surgery.
measure: Time to discharge
timeFrame: Trough hospital stay, an average of 1 week
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuzmayıs University
Study officials:
affiliation: Ondokuz Mayıs University
name: Yasemin Burcu Üstün
role: STUDY_DIRECTOR
References: