Preoperative Dexamethasone to Improve Quality of Recovery After Laparoscopic Bariatric Surgery

NCT ID: NCT05752734

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-02
• Study Completion Date: 2023-06-10

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

Conditions

Anesthesia; Analgesia; Acute Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group D

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

Group D

Intervention Type: 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.

Group C

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

Group C

Intervention Type: 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.

Interventions

Group D

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.

Intervention Type: DRUG

Group C

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.

Intervention Type: DRUG

Other Intervention Names

dexamethasone group; control group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ondokuz Mayıs University

OTHER

Sponsor Role: lead

Responsible Party

Yasemin Burcu Ustun

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yasemin Burcu Üstün

Role: STUDY_DIRECTOR

Ondokuz Mayıs University

Locations

Ondokuzmayıs University

Samsun, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

SLGQR402022

Identifier Type: -

Identifier Source: org_study_id