Preoperative Dexamethasone to Improve Quality of Recovery After Laparoscopic Bariatric Surgery

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05752734
• Other study ID #: SLGQR402022
• Status: Completed
• Start date: February 2, 2023
• Est. completion date: June 10, 2023

Study information

• Verified date: September 2023
• Source: Ondokuz Mayis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 10, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Analgesia
• Anesthesia

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Ondokuzmayis University	Samsun

Sponsors (1)

Lead Sponsor	Collaborator
Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Morphine consumption in the first 24 hours after surgery	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.	postoperative day 1
Secondary	The incidences of post-operative nausea and vomiting (PONV)	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)	postoperative day 1
Secondary	Time to first mobilization	The patients first mobilization time after the operation will be recorded.	Up to 24 hours after surgery.
Secondary	Time to discharge	The length of hospital stay will be recorded.	Trough hospital stay, an average of 1 week