AnesthesiaNCT05951686
The Effect of Anesthetic Methods on Gastrointestinal Motility
A study testing Desflurane, Remifentanil infusion and Fresh gas in people with Anesthesia and Total Intravenous Anesthesia, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The goal of this randomized controlled single blinded study is to compare the effect of the type of anesthesia on gastrointestinal motility in patients scheduled for laparoscopic sleeve gastrectomy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anesthesia, Total Intravenous Anesthesia
- What is being tested?
- Desflurane, Remifentanil infusion and Fresh gas
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2022to 31 Dec 2023
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-60 ages
- ASA II-III
- Patients scheduled for elective laparoscopic sleeve gastrectomy
- Body mass index 35 kg m2 and over
Who cannot join
- Hepatic disease
- Kidney disease
- Congestive heart disease
- Diabetes mellitus
- Neurological deficit
- Psychiatric disease
Show all 11Show fewer
- Pregnancy
- Delayed gastric empting
- Previous bariatric surgery
- Patient's refusal
- Open surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Bozyaka Training and Research Hospital
Izmir, Bozyaka
About this study
Official title: The Effect of Two Different Anesthetic Methods on Gastrointestinal Motility in Patients Scheduled for Laparoscopic Sleeve Gastrectomy: a Prospective, Randomized, Single Blinded Clinical Trial
The goal of this randomized controlled single blinded study is to compare the effect of the type of anesthesia on gastrointestinal motility in patients scheduled for laparoscopic sleeve gastrectomy. The main question it aims to answer is how do inhalation anesthesia and total intravenous anesthesia effect the gastrointestinal peristalsis during anastomosis.
Participants will be American Society of Anesthesiology (ASA) physical status II and III, between 18- 60 ages.
Researchers will compare inhalation anesthesia where desflurane is used with total intravenous anesthesia to see if the gastrointestinal motility differs between the groups.
Read the detailed description
Aim of this study is to evaluate the effect of two anesthetic methods on gastric motility during laparoscopic sleeve gastrectomy. Patients scheduled for laparoscopic sleeve gastrectomy with American Society of Anesthesiology (ASA) physical status II and III will enrolled into two groups. Computer based randomization will be used for the group selection. Patients will be monitored with standard monitorization (peripheral oxygen saturation, non-invasive blood pressure, 3-lead electrocardiography and patient state index (PSI)). Preoxygenation will be performed via a face mask with 6 L/min oxygen for 5 minutes. All patients will receive intravenous 2 mg/kg propofol, 0.25 mcg/kg/min remifentanil for anesthesia induction. Rocuronium bromide will be used intravenously with a dose of 0.6 mg/kg for muscle relaxation. Endotracheal intubation will be performed. In Group 1, inhalation anesthetic, desflurane and in Group 2, propofol infusion will be used with a 2 L/ min fresh gas flow as a mixture of 50 %- 50 % oxygen- medical air for maintenance of general anesthesia. Remifentanil infusion with a dose of 0.05-2 mcg/kg/min will be used in both groups during anesthesia maintenance. Anesthesia depth will be monitored with EEG monitorization where a score of 25-50 will be achieved in PSI . End-tidal carbon dioxide pressure will be kept between 35 and 45 mmHg. End-expiratory positive pressure will be set to 8 mmHg and intraabdominal pressure will be set to 12 mmHg. The surgeon will assess the gastric motility during anastomosis. The peristalsis during 1 minute period will be counted. 1 gram paracetamol and 1 mg/kg tramadol will be given intravenously for pain management. Sugammadex will be used for the reversal of neuromuscular blockade. Postoperative nause and vomiting, the time of first fart will be noted. Surgeon's satisfaction during anastomosis will be assessed with 5 points Likert Scale. Data will be statistically analyzed.
- Conditions
- Anesthesia, Total Intravenous Anesthesia
- Being tested
- Desflurane, Remifentanil infusion, Fresh gas, Propofol infusion
- Keywords
- gastric motility, laparoscopic sleeve gastrectomy, desflurane, propofol, remifentanil, peristalsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesfluraneDrug
Also called suprane
In inhalation group, desflurane will be used for general anesthesia maintenance under the screening with Patient State Index (PSI) between a score of 25-50. Remifentanil infusion is used with desflurane with a dose of 0.05-2 mcg/ kg/ min according to PSI . Fresh gas flow is used 2 L/ min with a mixture of 50%- 50% oxygen and medical air in both groups.
Remifentanil infusionDrug
Also called ultiva
Remifentanil infusion will be used with a dose of 0.05-2 mcg/ kg/ min under the screening with Patient State Index (PSI) between a score of 25-50 in both groups.
Fresh gasOther
Fresh gas flow will be used 2 L/ min with a mixture of 50%- 50% oxygen and medical air in both groups.
Propofol infusionDrug
Also called propofol 2%
Propofol infusion will be used for general anesthesia maintenance with a dose of under the screening of Patient State Index (PSI) between a score of 25-50 in group tiva.
| Study group | Role | What they receive |
|---|---|---|
| Group inhalation | Active comparator | Patients will receive desflurane as an inhalation anesthetic and remifentanil infusion for general anesthesia maintenance during the surgery. The doses of desflurane and remifentanil will be adjusted according to the Patient State Index (PSI) where the goal score is 25-50. Receives: Drug: Desflurane; Drug: Remifentanil infusion; Other: Fresh gas |
| Group tiva | Active comparator | Patients will receive total intravenous anesthesia with an infusion of propofol and remifentanil for general anesthesia maintenance during the surgery. The infusion doses will be changed according to the Patient State Index (PSI) where the goal score is 25-50. Receives: Drug: Remifentanil infusion; Other: Fresh gas; Drug: Propofol infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal motility
Gastrointestinal motility is the number of peristalsis during a one minute period. The surgeon will be asked to count the number of peristalsis during surgical anastomosis in a one minute period.
Measured: during surgery
Secondary outcomes (3)
Fart
The time of first fart
Measured: up to 24 hours after surgery
Nause and vomiting
Incidence of postoperative nause and vomiting
Measured: up to 24 hours after surgery
Satisfaction of surgeon
Ease of anastomosis and satisfaction of surgeon will be measured with 5 point Likert Scale as 1: very dissatisfied, 2:dissatisfied, 3: neither dissatisfied or satisfied, 4: satisfied, 5: very satisfied
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start15 Aug 2022
- Primary completion15 Oct 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozyaka Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halide Hande Şahinkaya, Bozyaka Training and Research Hospital
- Investigators
- Halide H Şahinkaya, MD, Principal investigator, Izmir Bozyaka Education and Research HospitalAhmet M Öztürk, MD, Study chair, Izmir Bozyaka Education and Research HospitalÇağlar Ayar, MD, Study chair, Izmir Bozyaka Education and Research HospitalHüseyin Özkarakaş, MD, Study chair, Izmir Bozyaka Education and Research HospitalBülent Çalık, Ass. Prof, Study chair, Izmir Bozyaka Education and Research HospitalZeki T Tekgül, Ass. Prof., Study chair, Izmir Bozyaka Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951686
- Sponsor's protocol ID
- HandeBariatric
- Status last verified
- Aug 2024
- First submitted
- 5 Jun 2023
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Akkurt BC, Temiz M, Inanoglu K, Aslan A, Turhanoglu S, Asfuroglu Z, Canbolant E. Comparison of recovery characteristics, postoperative nausea and vomiting, and gastrointestinal motility with total intravenous anesthesia with propofol versus inhalation anesthesia with desflurane for laparoscopic cholecystectomy: A randomized controlled study. Curr Ther Res Clin Exp. 2009 Apr;70(2):94-103. doi: 10.1016/j.curtheres.2009.04.002.
PubMed 24683221Liao Q, Wang MA, Ouyang W. [Effect of different anesthesias on gastrointestinal motility after laparoscopic cholecystectomy]. Hunan Yi Ke Da Xue Xue Bao. 2003 Feb 28;28(1):73-5. Chinese.
PubMed 12934407De Corte W, Delrue H, Vanfleteren LJ, Dutre PE, Pottel H, Devriendt DK, Van Rooy FH, D'Hondt M, Carlier S, Desmet MB. Randomized clinical trial on the influence of anaesthesia protocol on intestinal motility during laparoscopic surgery requiring small bowel anastomosis. Br J Surg. 2012 Nov;99(11):1524-9. doi: 10.1002/bjs.8883. Epub 2012 Sep 21.
PubMed 23001752
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Anesthetic Methods on Gastrointestinal Motility in Patients Scheduled for Laparoscopic Sleeve Gastrectomy: a Prospective, Randomized, Single Blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT05951686
- Acronym / sponsor ID
- HandeBariatric
- Conditions
- Anesthesia, Total Intravenous Anesthesia
- Keywords
- gastric motility, laparoscopic sleeve gastrectomy, desflurane, propofol, remifentanil, peristalsis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Bozyaka Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 19 Jul 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.
The goal of this randomized controlled single blinded study is to compare the effect of the type of anesthesia on gastrointestinal motility in patients scheduled for laparoscopic sleeve gastrectomy. The main question it aims to answer is how do inhalation anesthesia and total intravenous anesthesia effect the gastrointestinal peristalsis during anastomosis.
Participants will be American Society of Anesthesiology (ASA) physical status II and III, between 18- 60 ages.
Researchers will compare inhalation anesthesia where desflurane is used with total intravenous anesthesia to see if the gastrointestinal motility differs between the groups.
Detailed description
Aim of this study is to evaluate the effect of two anesthetic methods on gastric motility during laparoscopic sleeve gastrectomy. Patients scheduled for laparoscopic sleeve gastrectomy with American Society of Anesthesiology (ASA) physical status II and III will enrolled into two groups. Computer based randomization will be used for the group selection. Patients will be monitored with standard monitorization (peripheral oxygen saturation, non-invasive blood pressure, 3-lead electrocardiography and patient state index (PSI)). Preoxygenation will be performed via a face mask with 6 L/min oxygen for 5 minutes. All patients will receive intravenous 2 mg/kg propofol, 0.25 mcg/kg/min remifentanil for anesthesia induction. Rocuronium bromide will be used intravenously with a dose of 0.6 mg/kg for muscle relaxation. Endotracheal intubation will be performed. In Group 1, inhalation anesthetic, desflurane and in Group 2, propofol infusion will be used with a 2 L/ min fresh gas flow as a mixture of 50 %- 50 % oxygen- medical air for maintenance of general anesthesia. Remifentanil infusion with a dose of 0.05-2 mcg/kg/min will be used in both groups during anesthesia maintenance. Anesthesia depth will be monitored with EEG monitorization where a score of 25-50 will be achieved in PSI . End-tidal carbon dioxide pressure will be kept between 35 and 45 mmHg. End-expiratory positive pressure will be set to 8 mmHg and intraabdominal pressure will be set to 12 mmHg. The surgeon will assess the gastric motility during anastomosis. The peristalsis during 1 minute period will be counted. 1 gram paracetamol and 1 mg/kg tramadol will be given intravenously for pain management. Sugammadex will be used for the reversal of neuromuscular blockade. Postoperative nause and vomiting, the time of first fart will be noted. Surgeon's satisfaction during anastomosis will be assessed with 5 points Likert Scale. Data will be statistically analyzed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group inhalation | Active comparator | Drug: Desflurane, Drug: Remifentanil infusion, Other: Fresh gasPatients will receive desflurane as an inhalation anesthetic and remifentanil infusion for general anesthesia maintenance during the surgery. The doses of desflurane and remifentanil will be adjusted according to the Patient State Index (PSI) where the goal score is 25-50. |
| Group tiva | Active comparator | Drug: Remifentanil infusion, Other: Fresh gas, Drug: Propofol infusionPatients will receive total intravenous anesthesia with an infusion of propofol and remifentanil for general anesthesia maintenance during the surgery. The infusion doses will be changed according to the Patient State Index (PSI) where the goal score is 25-50. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-60 ages
- ASA II-III
- Patients scheduled for elective laparoscopic sleeve gastrectomy
- Body mass index 35 kg m2 and over
Key exclusion criteria (11 listed)
- Hepatic disease
- Kidney disease
- Congestive heart disease
- Diabetes mellitus
- Neurological deficit
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 |
|---|---|---|
| DesfluraneAlso: supraneIn inhalation group, desflurane will be used for general anesthesia maintenance under the screening with Patient State Index (PSI) between a score of 25-50. Remifentanil infusion is used with desflurane with a dose of 0.05-2 mcg/ kg/ min according to PSI . Fresh gas flow is used 2 L/ min with a mixture of 50%- 50% oxygen and medical air in both groups. | Drug | Group inhalation |
| Remifentanil infusionAlso: ultivaRemifentanil infusion will be used with a dose of 0.05-2 mcg/ kg/ min under the screening with Patient State Index (PSI) between a score of 25-50 in both groups. | Drug | Group inhalation, Group tiva |
| Fresh gasFresh gas flow will be used 2 L/ min with a mixture of 50%- 50% oxygen and medical air in both groups. | Other | Group inhalation, Group tiva |
| Propofol infusionAlso: propofol 2%Propofol infusion will be used for general anesthesia maintenance with a dose of under the screening of Patient State Index (PSI) between a score of 25-50 in group tiva. | Drug | Group tiva |
Primary outcome
Gastrointestinal motility
Time frame: during surgery
Gastrointestinal motility is the number of peristalsis during a one minute period. The surgeon will be asked to count the number of peristalsis during surgical anastomosis in a one minute period.
3 secondary outcomes
Fart
Time frame: up to 24 hours after surgery
Nause and vomiting
Time frame: up to 24 hours after surgery
Satisfaction of surgeon
Time frame: during surgery
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 13 Aug 2024.
- Background: PubMed 24683221Akkurt BC, Temiz M, Inanoglu K, Aslan A, Turhanoglu S, Asfuroglu Z, Canbolant E. Comparison of recovery characteristics, postoperative nausea and vomiting, and gastrointestinal motility with total intravenous anesthesia with propofol versus inhalation anesthesia with desflurane for laparoscopic cholecystectomy: A randomized controlled study. Curr Ther Res Clin Exp. 2009 Apr;70(2):94-103. doi: 10.1016/j.curtheres.2009.04.002.
- Background: PubMed 12934407Liao Q, Wang MA, Ouyang W. [Effect of different anesthesias on gastrointestinal motility after laparoscopic cholecystectomy]. Hunan Yi Ke Da Xue Xue Bao. 2003 Feb 28;28(1):73-5. Chinese.
- Background: PubMed 23001752De Corte W, Delrue H, Vanfleteren LJ, Dutre PE, Pottel H, Devriendt DK, Van Rooy FH, D'Hondt M, Carlier S, Desmet MB. Randomized clinical trial on the influence of anaesthesia protocol on intestinal motility during laparoscopic surgery requiring small bowel anastomosis. Br J Surg. 2012 Nov;99(11):1524-9. doi: 10.1002/bjs.8883. Epub 2012 Sep 21.
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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.
Halide H Şahinkaya, MD principal investigator
Izmir Bozyaka Education and Research Hospital
Ahmet M Öztürk, MD study chair
Izmir Bozyaka Education and Research Hospital
Çağlar Ayar, MD study chair
Izmir Bozyaka Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Desflurane, Remifentanil infusion and Fresh gas in people with Anesthesia and Total Intravenous Anesthesia, run by Bozyaka Training and Research Hospital 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 4 inclusion and 11 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 13 Aug 2024. 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?
Gastrointestinal motility (time frame: during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05951686, which also lists 3 linked publications.
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 13 Aug 2024.