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NCT Number: NCT05752734

Preoperative Dexamethasone to Improve Quality of Recovery After Laparoscopic Bariatric Surgery

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.

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Key information

Conditions

Anesthesia Acute Pain Agnosia Analgesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ondokuzmayıs University

Samsun, 55060, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

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.

Other names: dexamethasone group

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.

Other names: control group

Primary outcomes

  1. 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).

  2. 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

  1. Morphine consumption in the first 24 hours after surgery

    Time frame: postoperative day 1

    Morphine consumption in the first 24 hours will be measured. Patients will be able to request opioids via a PCA device when their NRS score ≥3.

  2. The incidences of post-operative nausea and vomiting (PONV)

    Time frame: postoperative day 1

    Post-operative nausea and vomiting (PONV) will be evaluated with a verbal descriptive scale.

    (0 = None at all, 1 = Mild nausea, 2 = Moderate nausea, 3 = Vomiting once, 4 = Vomiting more than once)

  3. Time to first mobilization

    Time frame: Up to 24 hours after surgery.

    The patients first mobilization time after the operation will be recorded.

  4. Time to discharge

    Time frame: Trough hospital stay, an average of 1 week

    The length of hospital stay will be recorded.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 3, 2023
Registry last updated
Sep 21, 2023

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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