AnesthesiaNCT05752734
Preoperative Dexamethasone to Improve Quality of Recovery After Laparoscopic Bariatric Surgery
An observational study of Anesthesia and Analgesia, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesia, Analgesia, Acute Pain
- What is being tested?
- Group D and Group C
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2023to 10 Jun 2023
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with BMI > 30 undergoing elective laparoscopic sleeve gastrectomy (LSG)
Who may be able to join
- 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
Who cannot join
- 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%),
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- uncontrolled hypertension,
- preoperative analgesic use,
- chronic pain,
- history of alcohol or drug addiction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Dexamethasone Enhances Quality of Recovery After Laparoscopic Bariatric Surgery: A Prospective Observational Study
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.
Read the 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
- Being tested
- Group D, Group C
- Keywords
- dexamethasone, quality of recovery-40, acute pain scores, morphine consumption
- Medical subject headings
- Agnosia, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group DDrug
Also called dexamethasone group
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 CDrug
Also called control group
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.
| Study group | Role | What they receive |
|---|---|---|
| Group D | Patients who used/applied dexamethasone before bariatric surgery were included in this group. Receives: Drug: Group D | |
| Group C | Patients who did not use dexamethasone or steroid-derived drugs were included in this group. Receives: Drug: Group C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: postoperative day 1
Secondary outcomes (4)
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.
Measured: postoperative day 1
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)
Measured: postoperative day 1
Time to first mobilization
The patients first mobilization time after the operation will be recorded.
Measured: Up to 24 hours after surgery.
Time to discharge
The length of hospital stay will be recorded.
Measured: Trough hospital stay, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start2 Feb 2023
- Primary completion1 Jun 2023
- Study completion10 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Burcu Ustun, Ondokuz Mayıs University
- Investigators
- Yasemin Burcu Üstün, Study director, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752734
- Sponsor's protocol ID
- SLGQR402022
- Status last verified
- Sep 2023
- First submitted
- 21 Feb 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Dexamethasone Enhances Quality of Recovery After Laparoscopic Bariatric Surgery: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05752734
- Acronym / sponsor ID
- SLGQR402022
- Conditions
- Anesthesia, Analgesia, Acute Pain
- Keywords
- dexamethasone, quality of recovery-40, acute pain scores, morphine consumption
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 10 Jun 2023 (actual)
- First posted
- 3 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group D | – | Drug: Group DPatients who used/applied dexamethasone before bariatric surgery were included in this group. |
| Group C | – | Drug: Group CPatients who did not use dexamethasone or steroid-derived drugs were included in this group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with BMI > 30 undergoing elective laparoscopic sleeve gastrectomy (LSG)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- refusal to participate
- allergy to the study drugs
- chronic kidney disease (creatinine>150 μmol/L)
- mental illness
- liver, respiratory or oncological disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group DAlso: dexamethasone groupPatients 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. | Drug | Group D |
| Group CAlso: control groupPatients 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. | Drug | Group C |
Primary outcome
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).
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).
4 secondary outcomes
Morphine consumption in the first 24 hours after surgery
Time frame: postoperative day 1
The incidences of post-operative nausea and vomiting (PONV)
Time frame: postoperative day 1
Time to first mobilization
Time frame: Up to 24 hours after surgery.
Time to discharge
Time frame: Trough hospital stay, an average of 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasemin Burcu Üstün study director
Ondokuz Mayıs University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Analgesia, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Quality of Recovery (QoR-40) score in the first 24 hours after surgery (time frame: postoperative day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.