CholecystitisPhase 4NCT06927817
The Effect of Hyoscine-n-butylbromide on Nausea and Pain in Laparoscopic Cholecystectomy
A Phase 4 study testing hyoscine-n-butylbromide, ondansetron and • hyoscine-n-butylbromide • ondansetron in people with Cholecystitis and Pain, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The goal of this randomized double blind study is to compare the effects of hyoscine-n-butylbromide, and ondansetron on postoperative nausea-vomiting, and pain in patients who underwent laparoscopic cholecystectomy.The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cholecystitis, Pain, Nausea
- What is being tested?
- hyoscine-n-butylbromide, ondansetron and • hyoscine-n-butylbromide • ondansetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2020to 8 Apr 2025
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA score of 1-2 who undergoing laparoscopic cholecystectomy 18-65 years of age
Who cannot join
- Patients who are allergic to the drugs used in the study, have an ASA score of 3-4, congestive heart failure or arrhythmia, motion sickness, central nervous system pathology, glaucoma, prostate hypertrophy, and a body mass index above 35, and used antihistamines will not included in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences Fatih Sultan Mehmet Health Research and Application Center,
Istanbul, Istanbul, 34668
About this study
Official title: The Effect of Hyoscine-N-Butylbromide on Nausea and Pain in Laparoscopic Cholecystectomy: A Prospective Randomized Study
The goal of this randomized double blind study is to compare the effects of hyoscine-n-butylbromide, and ondansetron on postoperative nausea-vomiting, and pain in patients who underwent laparoscopic cholecystectomy.The main questions it aims to answer are:
- Is antiemetic properties of hyoscine-n-butylbromide effective after laparoscopic cholecyctectomy?
- Does hyoscine-n-butylbromide have valuable effects on postoperative pain after laparoscopic cholecyctectomy?
Read more
Participants will be the paients undergoing laparoscopic cholecyctectomy.
The patients participating in the study were randomized into two groups as Group-HBB, and Group-O.
After the gallbladder removed, IV infusion of 1000 mg paracetamol, and 1.5 mg/kg tramadol will administered to the patients. 20 mg hyoscine-n-butylbromide in 100 ml saline will administered to the patients in Group-HBB, and 4 mg ondansetron infusion in 100 ml saline will be administered to the patients in Group-O.
Postoperative nausea and vomitting score and pain intensity and rescue drugs will be recorded in postoperative 24 hours.
Read the detailed description
After obtaining the informed consent form from the patients, a total of 134 patients undergoingt laparoscopic cholecystectomy surgery will be inclueded in the study. The patients participating in the study will be randomized into two groups as Group-HBB, and Group-O by the closed envelope method. The patients will be blinded to groups they belonged to. Routine peripheral oxygen saturation, noninvasive blood pressure, electrocardiography, and bispectral index (BIS) monitoring will be performed.. BIS-guided 2-2.5mg/kg propofol, and 2mcg/kg fentanyl intravenously, and 0.6mg/kg rocuronium injection will be administered. In order to maintain the BIS value between 40-60, 1-2% sevoflurane inhalation in 40/60% oxygen/air mixture in 2-liter flow, and 0.1-0.5mc/kg/min remifentanil infusion will be applied. After the gallbladder removed, IV infusion of 1000 mg paracetamol, and 1.5 mg/kg tramadol will administered to the patients. 20 mg hyoscine-n-butylbromide in 100 ml saline will administered to the patients in Group-HBB, and 4 mg ondansetron infusion in 100 ml saline will be administered to the patients in Group-O. After the surgery terminates, 2 mg/kg sugammadex will be used to antagonize the muscle relaxant effect, and patients with adequate respiratory effort, and a BIS value above 85 will be extubated.
Demographic data of the patients such as age, body mass index, gender, comorbidities, ASA score, and smoking status will be recorded. Nausea, vomiting, and pain status will be examined in the recovery unit at postoperative 15th, and 30th minutes and in the ward at the 3rd, 6th, 12th and 24th hours. Follow-ups will be performed by an anesthesiologist who is blind to groups of the patients. A 4-point scale will be used for nausea-vomiting (0: no nausea and vomiting, 1: nausea, no vomiting, 2: nausea, vomiting, 3: vomiting more than twice), and a 10 cm VAS score will be used for assessig the pain level. Patients with a pain level of 4 and above will be administered 20 mg of tenoxicam intravenously as an analgesic. If the nausea score is >0, 10 mg metoclopramide iv will be administered, and if the score was still >0 after 30 minutes, 4 mg dexamethasone iv will be administered.
- Conditions
- Cholecystitis, Pain, Nausea
- Being tested
- hyoscine-n-butylbromide, ondansetron, • hyoscine-n-butylbromide • ondansetron
- Keywords
- Hyoscine N-Butylbromide, Laparoscopic Cholecystectomy, Ondansetron, Pain, Postoperative Nausea and Vomiting
- Medical subject headings
- Cholecystitis, Pain, Nausea, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyoscine-n-butylbromide, ondansetronDrug
Also called • hyoscine-n-butylbromide • ondansetron
In patients in Group Hyoscine 20mg hyoscine-n-butylbromide in 100ml saline and in Group Ondansetron 4mg ondansetron infusion in 100ml saline will be administered in Group-O. The patients will be followed-up in terms of nausea, vomiting, and pain at the postoperative 15th, and 30th minutes and at the 3rd, 6th, 12th, and 24th hours.
• hyoscine-n-butylbromide • ondansetronDrug
In patients in Group Hyoscine 20mg hyoscine-n-butylbromide in 100ml saline and in Group Ondansetron 4mg ondansetron infusion in 100ml saline will be administered in Group-O. The patients will be followed-up in terms of nausea, vomiting, and pain at the postoperative 15th, and 30th minutes and at the 3rd, 6th, 12th, and 24th hours.
| Study group | Role | What they receive |
|---|---|---|
| hyoscine-n-butylbromide | Experimental | after removal of gall bladder 20mg hyoscine-n-butylbromide in 100ml saline wİll be administered Receives: Drug: hyoscine-n-butylbromide, ondansetron |
| ondansetron | Active comparator | 4mg ondansetron infusion in 100ml saline was administered Receives: Drug: • hyoscine-n-butylbromide • ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative nausea and vomiting
A 4-point scale will be used for nausea-vomiting (0: no nausea and vomiting, 1: nausea, no vomiting, 2: nausea, vomiting, 3: vomiting more than twice)
Measured: 15th, and 30th minutes and at the 3rd, 6th, 12th, and 24th hours.
Postoperative pain
10 cm VAS score will be used for assessig the pain level
Measured: 15th, and 30th minutes and at the 3rd, 6th, 12th, and 24th hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start15 Nov 2020
- Primary completion15 Nov 2021
- Study completion8 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholecystitisStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Süheyla Abitağaoğlu, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927817
- Sponsor's protocol ID
- no sponsorship
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 17 Apr 2025
- 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 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hyoscine-N-Butylbromide on Nausea and Pain in Laparoscopic Cholecystectomy: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT06927817
- Acronym / sponsor ID
- no sponsorship
- Conditions
- Cholecystitis, Pain, Nausea
- Keywords
- Hyoscine N-Butylbromide, Laparoscopic Cholecystectomy, Ondansetron, Pain, Postoperative Nausea and Vomiting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 8 Apr 2025 (actual)
- First posted
- 15 Apr 2025 (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 double blind study is to compare the effects of hyoscine-n-butylbromide, and ondansetron on postoperative nausea-vomiting, and pain in patients who underwent laparoscopic cholecystectomy.The main questions it aims to answer are:
- Is antiemetic properties of hyoscine-n-butylbromide effective after laparoscopic cholecyctectomy?
- Does hyoscine-n-butylbromide have valuable effects on postoperative pain after laparoscopic cholecyctectomy?
Participants will be the paients undergoing laparoscopic cholecyctectomy.
The patients participating in the study were randomized into two groups as Group-HBB, and Group-O.
After the gallbladder removed, IV infusion of 1000 mg paracetamol, and 1.5 mg/kg tramadol will administered to the patients. 20 mg hyoscine-n-butylbromide in 100 ml saline will administered to the patients in Group-HBB, and 4 mg ondansetron infusion in 100 ml saline will be administered to the patients in Group-O.
Postoperative nausea and vomitting score and pain intensity and rescue drugs will be recorded in postoperative 24 hours.
Detailed description
After obtaining the informed consent form from the patients, a total of 134 patients undergoingt laparoscopic cholecystectomy surgery will be inclueded in the study. The patients participating in the study will be randomized into two groups as Group-HBB, and Group-O by the closed envelope method. The patients will be blinded to groups they belonged to. Routine peripheral oxygen saturation, noninvasive blood pressure, electrocardiography, and bispectral index (BIS) monitoring will be performed.. BIS-guided 2-2.5mg/kg propofol, and 2mcg/kg fentanyl intravenously, and 0.6mg/kg rocuronium injection will be administered. In order to maintain the BIS value between 40-60, 1-2% sevoflurane inhalation in 40/60% oxygen/air mixture in 2-liter flow, and 0.1-0.5mc/kg/min remifentanil infusion will be applied. After the gallbladder removed, IV infusion of 1000 mg paracetamol, and 1.5 mg/kg tramadol will administered to the patients. 20 mg hyoscine-n-butylbromide in 100 ml saline will administered to the patients in Group-HBB, and 4 mg ondansetron infusion in 100 ml saline will be administered to the patients in Group-O. After the surgery terminates, 2 mg/kg sugammadex will be used to antagonize the muscle relaxant effect, and patients with adequate respiratory effort, and a BIS value above 85 will be extubated.
Demographic data of the patients such as age, body mass index, gender, comorbidities, ASA score, and smoking status will be recorded. Nausea, vomiting, and pain status will be examined in the recovery unit at postoperative 15th, and 30th minutes and in the ward at the 3rd, 6th, 12th and 24th hours. Follow-ups will be performed by an anesthesiologist who is blind to groups of the patients. A 4-point scale will be used for nausea-vomiting (0: no nausea and vomiting, 1: nausea, no vomiting, 2: nausea, vomiting, 3: vomiting more than twice), and a 10 cm VAS score will be used for assessig the pain level. Patients with a pain level of 4 and above will be administered 20 mg of tenoxicam intravenously as an analgesic. If the nausea score is >0, 10 mg metoclopramide iv will be administered, and if the score was still >0 after 30 minutes, 4 mg dexamethasone iv will be administered.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyoscine-n-butylbromide | Experimental | Drug: hyoscine-n-butylbromide, ondansetronafter removal of gall bladder 20mg hyoscine-n-butylbromide in 100ml saline wİll be administered |
| ondansetron | Active comparator | Drug: • hyoscine-n-butylbromide • ondansetron4mg ondansetron infusion in 100ml saline was administered |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA score of 1-2 who undergoing laparoscopic cholecystectomy 18-65 years of age
Key exclusion criteria (1 listed)
- Patients who are allergic to the drugs used in the study, have an ASA score of 3-4, congestive heart failure or arrhythmia, motion sickness, central nervous system pathology, glaucoma, prostate hypertrophy, and a body mass index above 35, and used antihistamines will not included in the study
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 |
|---|---|---|
| hyoscine-n-butylbromide, ondansetronAlso: • hyoscine-n-butylbromide • ondansetronIn patients in Group Hyoscine 20mg hyoscine-n-butylbromide in 100ml saline and in Group Ondansetron 4mg ondansetron infusion in 100ml saline will be administered in Group-O. The patients will be followed-up in terms of nausea, vomiting, and pain at the postoperative 15th, and 30th minutes and at the 3rd, 6th, 12th, and 24th hours. | Drug | hyoscine-n-butylbromide |
| • hyoscine-n-butylbromide • ondansetronIn patients in Group Hyoscine 20mg hyoscine-n-butylbromide in 100ml saline and in Group Ondansetron 4mg ondansetron infusion in 100ml saline will be administered in Group-O. The patients will be followed-up in terms of nausea, vomiting, and pain at the postoperative 15th, and 30th minutes and at the 3rd, 6th, 12th, and 24th hours. | Drug | ondansetron |
Primary outcome
postoperative nausea and vomiting
Time frame: 15th, and 30th minutes and at the 3rd, 6th, 12th, and 24th hours.
A 4-point scale will be used for nausea-vomiting (0: no nausea and vomiting, 1: nausea, no vomiting, 2: nausea, vomiting, 3: vomiting more than twice)
Postoperative pain
Time frame: 15th, and 30th minutes and at the 3rd, 6th, 12th, and 24th hours.
10 cm VAS score will be used for assessig the pain level
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 17 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing hyoscine-n-butylbromide, ondansetron and • hyoscine-n-butylbromide • ondansetron in people with Cholecystitis and Pain, run by Saglik Bilimleri Universitesi 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 1 inclusion and 1 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 17 Apr 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
postoperative nausea and vomiting (time frame: 15th, and 30th minutes and at the 3rd, 6th, 12th, and 24th hours.). 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 17 Apr 2025.