Preoperative Dexamethasone to Improve Quality of Recovery After Laparoscopic Bariatric Surgery

NCT05752734 | Completed

• 1 other identifier: SLGQR402022
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Analgesia; Acute Pain

Keywords

dexamethasone; quality of recovery-40; acute pain scores; morphine consumption

Outcome Measures

Primary Outcomes (2)

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

  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).

  postoperative day 1

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

  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).

  postoperative day 1

Secondary Outcomes (4)

• 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

Study Arms (2)

Group D

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

Drug: Group D

Group C

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

Drug: Group C

Interventions

Group D DRUG

Patients who received 8 mg dexamethasone before bariatric surgery will be included in this group. Multimodal analgesia protocol is applied to all patients undergoing bariatric surgery in our clinic. According to this protocol, patients are administered iv tenoxicam 20mg, tramadol 100mg after induction of general anesthesia, and iv morphine (0.05mg/kg/IBW) intraoperatively. Postoperative analgesia: iv paracetamol 1gr every 8 hours and iv pca of 0,4mg/ml morphine (the bolus dose is 1mg, the lock-in time of 15 minutes, the 4-hour limit is adjusted to be 40% of the calculated total dose). In cases where rescue analgesia is required (VAS score ≥3) 0.5 mg/kg tramadol is administered to patients. For postoperative nausea and vomiting prophylaxis, patients are routinely administered ondansetron 4 mg IV 20 minutes before extubation.

Also known as: dexamethasone group

Group D

Group C DRUG

Patients not administered dexamethasone will be included in this group. Multimodal analgesia protocol is applied to all patients undergoing bariatric surgery in our clinic. According to this protocol, patients are administered iv tenoxicam 20mg, tramadol 100mg after induction of general anesthesia, and iv morphine (0.05mg/kg/IBW) intraoperatively. Postoperative analgesia: iv paracetamol 1gr every 8 hours and iv pca of 0,4mg/ml morphine (the bolus dose is 1mg, the lock-in time of 15 minutes, the 4-hour limit is adjusted to be 40% of the calculated total dose). In cases where rescue analgesia is required (VAS score ≥3) 0.5 mg/kg tramadol is administered to patients. For postoperative nausea and vomiting prophylaxis, patients are routinely administered ondansetron 4 mg IV 20 minutes before extubation.

Also known as: control group

Group C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with BMI \> 30 undergoing elective laparoscopic sleeve gastrectomy (LSG)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuzmayıs University

Samsun, 55060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia; Acute Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Yasemin Burcu Üstün

  Ondokuz Mayıs University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 3, 2023
• Study Start: February 2, 2023
• Primary Completion: June 1, 2023
• Study Completion: June 10, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

TU (1)