CholelithiasisPhase 4lapNCT03180229
Granisetron Effect on Hemodynamic Changes in Laparoscopic Cholecystectomy
A Phase 4 study testing Granisetron 1 Mg/mL Intravenous Solution in people with Cholelithiasis, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Propofol is one of the most commonly used anesthetic agents because of its ability to induce rapid and reliable collection. However, hypotension and injection pain in the induction are the most common complications. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cholelithiasis
- What is being tested?
- Granisetron 1 Mg/mL Intravenous Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 May 2017to 26 Dec 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Laparoscopic Cholecystectomy (lap) surgery
Who cannot join
- Acute pancreatitis disease
- Cardiorespiratory disease
- Hypertension
- Anti hypertension treatments
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital Ankara, Turkey
Ankara
About this study
Official title: Granisetron Effect on Hemodynamic Changes and Intubation Condition During Anesthesia Induction in Laparoscopic Cholecystectomy
Propofol is one of the most commonly used anesthetic agents because of its ability to induce rapid and reliable collection. However, hypotension and injection pain in the induction are the most common complications. After induction of propofol; The cardiovascular system depresses, resulting in a drop in blood pressure due to decreased cardiac output and systemic vascular resistance. This may also contribute to the reduction of sympathetic tone activity in the central way, and slight reduction in the number of pulses that develop as a result of increasing vagal activity. İn order to attenuate these hemodynamic undesired effects caused by propofol, various agents were tried such as atropine, ephedrine, volume replacement ringer lactate, ketamine. Ondansetron and granisetron, which are used for postoperative nausea and vomiting prophylaxis, have been used as such. Therefore, ondansetron and granisetron were preventing hypotension induced by post-spinal and general anesthesia induction.
The investigator also tried to demonstrate the effect of granisetron, another serotonin type 3 (5-HT3) receptor antagonist for postoperative nausea and vomiting prophylaxis, on induction hypotension and intubation quality after propofol induction in this study
Read the detailed description
150 participants with American Society of Anesthesiologists (ASA) physical score I-II who underwent elective laparoscopic cholecystectomy between the ages of 18-70 will be enrolled. Participants will be divided into two groups using granisetron and control.
All participants will be premedicated with 0.05 mg kg-1 midazolam 30 minutes before the operation. ASA, age, sex, weight demographic data of the participants who were taken to the operating room will record. Peripheral oxygen saturation (SPO2), noninvasive blood pressure and electrocardiography (ECG) will monitored. A venous cannula will place on the back of the hand. Participants will randomly divide into 2 groups by closed envelope method.
Five minutes before the induction of group G, 1 ml (1 mg / ml) iv granisetron, group K will receive 1 ml saline. Propofol at induction will be administered at a dose of 0.6 mg / kg of rocuronium at a dose of 2 mg / kg. Pre-induction, post-intubation and every five minutes SPO2, diastolic arterial pressure (DAP), mean arterial pressure (MAP), systolic arterial pressure(SAP) and heart rate (HR) will record. Intubation quality will be evaluated by evans score.
Systolic Blood Pressure <Control + 15 0 <Control + 30 1 1
- Control + 30 2 Heart Rate Pressure <Control + 15 0 <Control + 30 1
- Control + 30 2 Sweating No 0 Moist leather 1 Visible sweating 2 Tears No 0 Yes 1 Overflowing 2
- Conditions
- Cholelithiasis
- Being tested
- Granisetron 1 Mg/mL Intravenous Solution
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Granisetron 1 Mg/mL Intravenous SolutionDrug
1 milligram (mg) will use on group Granisetron before 5 min induction
| Study group | Role | What they receive |
|---|---|---|
| Granisetron | Active comparator | Five minutes before the induction 1 ml (1 mg / ml) iv granisetron will use. .Then blood pressure (systolic, diastolic, mean) and heart rate will record per 5 minute during surgery. Receives: Drug: Granisetron 1 Mg/mL Intravenous Solution |
| Control | No intervention | Five minutes before the induction 1 ml saline iv use.Then blood pressure (systolic, diastolic, mean) and heart rate will record per 5 minute during surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change mean arterial blood pressure
mean arterial blood pressure (MAP) MAP at least 25% less than the basal value
Measured: Change from Baseline Systolic Blood Pressure at per 5 minute during surgery
intubation quality
in this time evans score which is included tears, sweating, systolic arterial blood pressure and heart rate will be used. the change baseline systolic arterial blood pressure and heart rate and tears, sweating will score numeric.
Measured: intubation period
change heart rate
HR <60 or >25% drop baseline
Measured: Change from baseline heart rate at per 5 minute during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start29 May 2017
- Primary completion1 Sep 2017
- Study completion26 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholelithiasisStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Savas Altinsoy, Diskapi Yildirim Beyazit Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180229
- Sponsor's protocol ID
- Diskapi
- Acronym
- lap
- Status last verified
- Sep 2019
- First submitted
- 29 May 2017
- Last updated
- 1 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Granisetron Effect on Hemodynamic Changes and Intubation Condition During Anesthesia Induction in Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT03180229
- Acronym / sponsor ID
- lap / Diskapi
- Conditions
- Cholelithiasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 29 May 2017 (actual)
- Primary completion
- 1 Sep 2017 (actual)
- Study completion
- 26 Dec 2018 (actual)
- First posted
- 8 Jun 2017 (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.
Propofol is one of the most commonly used anesthetic agents because of its ability to induce rapid and reliable collection. However, hypotension and injection pain in the induction are the most common complications. After induction of propofol; The cardiovascular system depresses, resulting in a drop in blood pressure due to decreased cardiac output and systemic vascular resistance. This may also contribute to the reduction of sympathetic tone activity in the central way, and slight reduction in the number of pulses that develop as a result of increasing vagal activity. İn order to attenuate these hemodynamic undesired effects caused by propofol, various agents were tried such as atropine, ephedrine, volume replacement ringer lactate, ketamine. Ondansetron and granisetron, which are used for postoperative nausea and vomiting prophylaxis, have been used as such. Therefore, ondansetron and granisetron were preventing hypotension induced by post-spinal and general anesthesia induction.
The investigator also tried to demonstrate the effect of granisetron, another serotonin type 3 (5-HT3) receptor antagonist for postoperative nausea and vomiting prophylaxis, on induction hypotension and intubation quality after propofol induction in this study
Detailed description
150 participants with American Society of Anesthesiologists (ASA) physical score I-II who underwent elective laparoscopic cholecystectomy between the ages of 18-70 will be enrolled. Participants will be divided into two groups using granisetron and control.
All participants will be premedicated with 0.05 mg kg-1 midazolam 30 minutes before the operation. ASA, age, sex, weight demographic data of the participants who were taken to the operating room will record. Peripheral oxygen saturation (SPO2), noninvasive blood pressure and electrocardiography (ECG) will monitored. A venous cannula will place on the back of the hand. Participants will randomly divide into 2 groups by closed envelope method.
Five minutes before the induction of group G, 1 ml (1 mg / ml) iv granisetron, group K will receive 1 ml saline. Propofol at induction will be administered at a dose of 0.6 mg / kg of rocuronium at a dose of 2 mg / kg. Pre-induction, post-intubation and every five minutes SPO2, diastolic arterial pressure (DAP), mean arterial pressure (MAP), systolic arterial pressure(SAP) and heart rate (HR) will record. Intubation quality will be evaluated by evans score.
Systolic Blood Pressure <Control + 15 0 <Control + 30 1 1
- Control + 30 2 Heart Rate Pressure <Control + 15 0 <Control + 30 1
- Control + 30 2 Sweating No 0 Moist leather 1 Visible sweating 2 Tears No 0 Yes 1 Overflowing 2
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Granisetron | Active comparator | Drug: Granisetron 1 Mg/mL Intravenous SolutionFive minutes before the induction 1 ml (1 mg / ml) iv granisetron will use. .Then blood pressure (systolic, diastolic, mean) and heart rate will record per 5 minute during surgery. |
| Control | No intervention | –Five minutes before the induction 1 ml saline iv use.Then blood pressure (systolic, diastolic, mean) and heart rate will record per 5 minute during surgery. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Laparoscopic Cholecystectomy (lap) surgery
Key exclusion criteria (4 listed)
- Acute pancreatitis disease
- Cardiorespiratory disease
- Hypertension
- Anti hypertension treatments
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 |
|---|---|---|
| Granisetron 1 Mg/mL Intravenous Solution1 milligram (mg) will use on group Granisetron before 5 min induction | Drug | Granisetron |
Primary outcome
change mean arterial blood pressure
Time frame: Change from Baseline Systolic Blood Pressure at per 5 minute during surgery
mean arterial blood pressure (MAP) MAP at least 25% less than the basal value
intubation quality
Time frame: intubation period
in this time evans score which is included tears, sweating, systolic arterial blood pressure and heart rate will be used. the change baseline systolic arterial blood pressure and heart rate and tears, sweating will score numeric.
change heart rate
Time frame: Change from baseline heart rate at per 5 minute during surgery
HR <60 or >25% drop baseline
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 1 Oct 2019.
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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 Granisetron 1 Mg/mL Intravenous Solution in people with Cholelithiasis, run by Diskapi Yildirim Beyazit Education 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 1 inclusion and 4 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 1 Oct 2019. 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?
change mean arterial blood pressure (time frame: Change from Baseline Systolic Blood Pressure at per 5 minute during surgery). The study lists 3 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 1 Oct 2019.