AnesthesiaNCT04178785
Remifentanil Versus Fentanyl During Laparoscopic Hysterectomy
A study testing Remifentanil in people with Anesthesia, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
Introduction- During laparoscopic procedures surgical field exposure is one of the crucial aspects for a successful surgery. Exposure can be optimized by pneumoperitoneum, positioning of the patient and muscle relaxation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anesthesia
- What is being tested?
- Remifentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteIsrael
- Study dates
- 22 Oct 2019to 1 Nov 2020
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >18
- scheduled for laparoscopic hysterectomy
Who cannot join
- known allergy to medications that are included in the trial, severe renal disease or impaired liver function
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Wolfson medical center
Holon
Hadas Miremberg, MD, 972526741740, dasile2@gmail.com
About this study
Official title: Remifentanil Versus Fentanyl During Laparoscopic Hysterectomy- a Randomized Control Trial
Introduction- During laparoscopic procedures surgical field exposure is one of the crucial aspects for a successful surgery. Exposure can be optimized by pneumoperitoneum, positioning of the patient and muscle relaxation.
The European Association for Endoscopic Surgery has recommended using the lowest intraperitoneal pressure allowing adequate exposure of the operative field rather than using a routine pressure. A way to lower intraabdominal pressure during laparoscopic procedures is to employ a deeper level of neuromuscular blockade.
Read more
Intravenous (IV) opioids such as fentanyl and remifentanil are commonly used to provide analgesia and supplement sedation during general anesthesia.
In terms of analgesia, management of intraoperative stress, remifentanil exhibits similar effects to fentanyl in adult healthy volunteers and surgical patients.
In clinical practice, if the surgeon asks for relaxation toward the end of the surgery, then many anesthesiologists will increase the dose of the IV opioids. In our experience the use of remifentanil achieves a better muscle relaxation and surgical space exposure with a lower intraabdominal pressure and less need for a neuromuscular blockage as compared to fentanyl.
Thus, the investigators aimed to compare the use of fentanyl versus remifentanil during laparoscopic hysterectomy. Because surgical complications due to inadequate exposure are a rare event, the typical way to study this issue is to use surgeon's satisfaction score.
Read the detailed description
Study design- Prospective, single-center single blind randomized controlled trial. Patients electively admitted for laparoscopic hysterectomy will be approached for requirement. After obtaining a written informed consent, patients will be randomly assigned either to the study group (Remifentanil group) or to the control group (Fentanyl group) in a 1:1 ratio. A blocked randomization scheme will be created using a computer-generated list of random numbers.
study protocol-
- anesthesia is induced and maintained with propofol
- Ventilation is performed with volume/pressure control mode with a tidal volume of 6-8 ml/kg, a frequency of 10-12/min and a positive end-expiratory pressure of 5 cm H2O aiming at normocapnia.
- Tracheal intubation is performed 2 min after administration of the muscle relaxant 0.6-1.2 mg/kg rocuronium.
- Patients in the study group will receive 0.2 mcg/kg/min Remifentanil
- Fentanyl at the dose of 100mcg will be administered to all the patients in the control group
- The gynecologist, surgical staff and patients will be blinded to group allocation.
- During surgery additional muscle relaxant will be given only when asked by the gynecologist and will be mentioned in the anesthesiologic chart
- The investigator managed the insufflation of the abdomen to 12 mmHg pneumoperitoneum.
- Patients will be placed in the lithotomy position in a 30-degree head-down body position.
- Antibiotic prophylaxis is given for all patients
- The gynecologists will evaluate the surgical conditions before a colpotomy is made in a circumferential fashion around the cervix and toward the end of the surgery on four-point rating scale (1: excellent, 2: good, 3: acceptable 4: poor)
- The gynecologists will also rate surgical space conditions on a numeric rating scale (NRS), where NRS 0 indicated optimal surgical space conditions and NRS 100 indicated unacceptable surgical space conditions and an intervention is needed to secure acceptable surgical space6
- Conditions
- Anesthesia
- Being tested
- Remifentanil
- Keywords
- laparoscopic, remifentanil, fentanyl, hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Patients electively admitted for laparoscopic hysterectomy will be approached for requirement. After obtaining a written informed consent, patients will be randomly assigned either to the study group (Remifentanil group) or to the control group (Fentanyl group) in a 1:1 ratio.
| Study group | Role | What they receive |
|---|---|---|
| REMIFENATIL | Active comparator | Prospective, single-center single blind randomized controlled trial. Patients electively admitted for laparoscopic hysterectomy will be approached for requirement. After obtaining a written informed consent, patients will be randomly assigned either to the study group (Remifentanil group) or to the control group (Fentanyl group) in a 1:1 ratio. A blocked randomization scheme will be created using a computer-generated list of random numbers. Receives: Drug: Remifentanil |
| FENTANYL | No intervention | Prospective, single-center single blind randomized controlled trial. Patients electively admitted for laparoscopic hysterectomy will be approached for requirement. After obtaining a written informed consent, patients will be randomly assigned either to the study group (Remifentanil group) or to the control group (Fentanyl group) in a 1:1 ratio. A blocked randomization scheme will be created using a computer-generated list of random numbers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical space conditions with modification of a 4-point scale. AT TIME OF COLPOTOMY
- grade 1 (optimal) = optimal surgical space conditions;
- grade 2 (good) = nonoptimal conditions, but an intervention was not considered;
- grade 3 (acceptable) = an intervention was considered to improve surgical space;
- grade 4 (poor) = inadequate conditions and an intervention was necessary to ensure acceptable surgical space.
Measured: through study completion, an average of 1 year
Surgical space conditions with modification of a 4-point scale. AT THE END OF SURGERY
- grade 1 (optimal) = optimal surgical space conditions;
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
surgical space conditions on a numeric rating scale (NRS)
where NRS 0 indicated optimal surgical space conditions and NRS 100 indicated unacceptable surgical space conditions and an intervention is needed to secure acceptable surgical space
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start22 Oct 2019
- Primary completion22 Oct 2020 (estimated)
- Study completion1 Nov 2020 (estimated)
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178785
- Sponsor's protocol ID
- 0038-19-WOMC
- Status last verified
- Nov 2019
- First submitted
- 22 Oct 2019
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remifentanil Versus Fentanyl During Laparoscopic Hysterectomy- a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04178785
- Acronym / sponsor ID
- 0038-19-WOMC
- Conditions
- Anesthesia
- Keywords
- laparoscopic, remifentanil, fentanyl, hysterectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 22 Oct 2020 (estimated)
- Study completion
- 1 Nov 2020 (estimated)
- First posted
- 26 Nov 2019 (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.
Introduction- During laparoscopic procedures surgical field exposure is one of the crucial aspects for a successful surgery. Exposure can be optimized by pneumoperitoneum, positioning of the patient and muscle relaxation.
The European Association for Endoscopic Surgery has recommended using the lowest intraperitoneal pressure allowing adequate exposure of the operative field rather than using a routine pressure. A way to lower intraabdominal pressure during laparoscopic procedures is to employ a deeper level of neuromuscular blockade.
Intravenous (IV) opioids such as fentanyl and remifentanil are commonly used to provide analgesia and supplement sedation during general anesthesia.
In terms of analgesia, management of intraoperative stress, remifentanil exhibits similar effects to fentanyl in adult healthy volunteers and surgical patients.
In clinical practice, if the surgeon asks for relaxation toward the end of the surgery, then many anesthesiologists will increase the dose of the IV opioids. In our experience the use of remifentanil achieves a better muscle relaxation and surgical space exposure with a lower intraabdominal pressure and less need for a neuromuscular blockage as compared to fentanyl.
Thus, the investigators aimed to compare the use of fentanyl versus remifentanil during laparoscopic hysterectomy. Because surgical complications due to inadequate exposure are a rare event, the typical way to study this issue is to use surgeon's satisfaction score.
Detailed description
Study design- Prospective, single-center single blind randomized controlled trial. Patients electively admitted for laparoscopic hysterectomy will be approached for requirement. After obtaining a written informed consent, patients will be randomly assigned either to the study group (Remifentanil group) or to the control group (Fentanyl group) in a 1:1 ratio. A blocked randomization scheme will be created using a computer-generated list of random numbers.
study protocol-
- anesthesia is induced and maintained with propofol
- Ventilation is performed with volume/pressure control mode with a tidal volume of 6-8 ml/kg, a frequency of 10-12/min and a positive end-expiratory pressure of 5 cm H2O aiming at normocapnia.
- Tracheal intubation is performed 2 min after administration of the muscle relaxant 0.6-1.2 mg/kg rocuronium.
- Patients in the study group will receive 0.2 mcg/kg/min Remifentanil
- Fentanyl at the dose of 100mcg will be administered to all the patients in the control group
- The gynecologist, surgical staff and patients will be blinded to group allocation.
- During surgery additional muscle relaxant will be given only when asked by the gynecologist and will be mentioned in the anesthesiologic chart
- The investigator managed the insufflation of the abdomen to 12 mmHg pneumoperitoneum.
- Patients will be placed in the lithotomy position in a 30-degree head-down body position.
- Antibiotic prophylaxis is given for all patients
- The gynecologists will evaluate the surgical conditions before a colpotomy is made in a circumferential fashion around the cervix and toward the end of the surgery on four-point rating scale (1: excellent, 2: good, 3: acceptable 4: poor)
- The gynecologists will also rate surgical space conditions on a numeric rating scale (NRS), where NRS 0 indicated optimal surgical space conditions and NRS 100 indicated unacceptable surgical space conditions and an intervention is needed to secure acceptable surgical space6
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REMIFENATIL | Active comparator | Drug: RemifentanilProspective, single-center single blind randomized controlled trial. Patients electively admitted for laparoscopic hysterectomy will be approached for requirement. After obtaining a written informed consent, patients will be randomly assigned either to the study group (Remifentanil group) or to the control group (Fentanyl group) in a 1:1 ratio. A blocked randomization scheme will be created using a computer-generated list of random numbers. |
| FENTANYL | No intervention | –Prospective, single-center single blind randomized controlled trial. Patients electively admitted for laparoscopic hysterectomy will be approached for requirement. After obtaining a written informed consent, patients will be randomly assigned either to the study group (Remifentanil group) or to the control group (Fentanyl group) in a 1:1 ratio. A blocked randomization scheme will be created using a computer-generated list of random numbers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age >18
- scheduled for laparoscopic hysterectomy
Key exclusion criteria (1 listed)
- known allergy to medications that are included in the trial, severe renal disease or impaired liver function
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 |
|---|---|---|
| RemifentanilPatients electively admitted for laparoscopic hysterectomy will be approached for requirement. After obtaining a written informed consent, patients will be randomly assigned either to the study group (Remifentanil group) or to the control group (Fentanyl group) in a 1:1 ratio. | Drug | REMIFENATIL |
Primary outcome
Surgical space conditions with modification of a 4-point scale. AT TIME OF COLPOTOMY
Time frame: through study completion, an average of 1 year
1. grade 1 (optimal) = optimal surgical space conditions; 2. grade 2 (good) = nonoptimal conditions, but an intervention was not considered; 3. grade 3 (acceptable) = an intervention was considered to improve surgical space; 4. grade 4 (poor) = inadequate conditions and an intervention was necessary to ensure acceptable surgical space.
Surgical space conditions with modification of a 4-point scale. AT THE END OF SURGERY
Time frame: through study completion, an average of 1 year
1. grade 1 (optimal) = optimal surgical space conditions;
1 secondary outcome
surgical space conditions on a numeric rating scale (NRS)
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remifentanil in people with Anesthesia, run by Wolfson Medical Center at 1 site in Israel.
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 2 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: status not confirmed, as of the sponsor's last update on 26 Nov 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MIchal De Wolf (9725028346, michald@wmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical space conditions with modification of a 4-point scale. AT TIME OF COLPOTOMY (time frame: through study completion, an average of 1 year). 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 26 Nov 2019.