Bowel DiseasePhase 2/3NCT04021264
The Impact of an Epidural Anesthetic on the Consumption of Sevoflurane in Major Abdominal Surgery
A Phase 2/3 study testing Ropivacaine-Sufentanil and Dextrose 5 in people with Bowel Disease and Liver Diseases, run by University of Alberta at 1 site in Canada.
Trial summary
Major abdominal surgery - like non-laparoscopic bowel resection, liver, gastric, or pancreas surgery - is performed under general anesthesia. Pain control for after the surgery can be achieved purely with intravenous and oral pain medication or in combination with freezing of the nerves. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bowel Disease, Liver Diseases, Pancreas Disease
- What is being tested?
- Ropivacaine-Sufentanil and Dextrose 5
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2019to 1 Jan 2022
- Phase
- Phase 2/3
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing elective reconstructive foot and ankle surgery
- Patients eligible for popliteal and saphenous nerve block
- All adults 18 years of age or older
- Capable to give consent
Who cannot join
- Patients who are unable to give consent
- Local anaesthetic allergy
- Hemidiaphragm paresis on the contralateral side to the block/surgery site
- Bleeding diathesis
- Coagulopathy
- Pre-existing neurological deficits
- Patients with a Body Mass Index >35
- Patients with significant comorbidities, physiological limitations, and allergies that are unable to tolerate the protocolized induction and maintenance of anesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
Major abdominal surgery - like non-laparoscopic bowel resection, liver, gastric, or pancreas surgery - is performed under general anesthesia. Pain control for after the surgery can be achieved purely with intravenous and oral pain medication or in combination with freezing of the nerves. Nerve freezing (nerve block) placed before surgery has the potential to substantially reduce the amount of inhaled anesthetic given to the patient during surgery. This can benefit the patient with being more awake and crisp more quickly after surgery. It can also reduce cost to the system. A further benefit which has received very little attention so far, is that reducing the amount of inhaled anesthetic given also lowers the environmental footprint created by the anesthetic.
The investigators of the proposed study plan to quantify the amount of inhaled anesthetic used for each case and will compare how the consumption is affected by whether the epidural block is applied before or after surgery. Patients will have a nerve block catheter (epidural catheter) placed prior to the induction of general anesthetic by an experienced regional anesthesiologist. The epidural catheter will be bolused with a solution to which the anesthesiologist is blinded which will either be local anesthetic or dextrose (sham). The general anesthetic will be conducted according to a the protocol with the aim of maintaining a standard anesthetic depth monitored by patient state index (PSI). Measurements of the MAC-Value (minimum alveolar concentration) of inhaled anesthetic will be recorded every five minutes and will be noted down by a blinded observer. At the end of the case the anesthesiologist blinded to the solution will inject another solution (now a dextrose (sham) or local anesthetic before the patient is woken up.
Read the detailed description
Following ethics approval, eligible patients meeting the inclusion/exclusion criteria will be consented in pre-assessment unit or day surgery ward at least 2 hours prior to their surgery. Patients will then be randomized into two groups:
Epidural catheter insertion with 14 mL of a solution containing 0.125% bupivacaine and 2 mcg/ml sufentanil injection (Treatment group) Epidural catheter insertion with 14 mL normal saline injection (Sham group) The patient, anesthesia provider, data recorder, OR staff and Post Anaesthetic Care Unit (PACU) nurses, will be blinded at the beginning of the case. After randomization, each patient will receive a clear 20 mL syringe containing either the Treatment or the Sham solution. Prior to induction of general anesthesia, an epidural catheter will be inserted by an experienced acute pain physician who has been performing epidural blocks for at least 5 years. Catheter placement will be verified by a single test dose of 60 mg lidocaine to exclude subarachnoid tip location.
Induction of general anesthesia will follow a standardized protocol with the intravenous administration of fentanyl (2 mcg/kg), propofol (2 mg/kg), and rocuronium (0.6 mg/kg). General anesthesia will initially be maintained with sevoflurane at 1.0 age-adjusted Minimal Alveolar Concentration (MAC). Subsequently, the age-adjusted MAC will be titrated to achieve an intraoperative PSI target of 25-50 (Sedline, Masimo®), and intraoperative heart rate (HR) and mean blood pressure (MBP) target of +/-30% baseline values. The anaesthesiologist will have the ability to administer IV boluses of analgesic (remifentanil 0.5mcg/kg) at if the PSI is <50 and the MBP or HR is above 30% of baseline. Vasopressors such as phenylephrine (100 mcg IV bolus) and ephedrine (5 mg IV bolus) can be used as last-line therapy to treat hypotension that is unresponsive to MAC adjustments. The age-adjusted MAC value will be recorded every 5 minutes starting at the time of skin incision until the time of skin closure. In addition, intraoperative analgesic and vasopressor usage are recorded. The epidural catheter will be run continuously throughout the surgery with 4-6 ml/h with study drug number 1 as per randomization - so either treatment or sham. After the conclusion of MAC recording and prior to emergence from general anesthesia, the anaesthesiologist will be unblinded to the randomized groups, and the patients who received Sham solution will be given 20 mL of the treatment solution via the interscalene catheter to ensure patients receive adequate analgesia postoperatively.
Postoperatively, patients will be transported to PACU where the distribution of the sensory or motor block will then be checked and recorded 30 minutes after arriving in PACU in both groups. The NRS for pain will also be recorded in PACU at 0, 15, 30 and 45 minutes.
- Being tested
- Ropivacaine-Sufentanil, Dextrose 5
- Keywords
- Major abdominal surgery, epidural, environmental footprint
- Medical subject headings
- Intestinal Diseases, Liver Diseases, Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine-SufentanilDrug
Local anesthetic injection
Dextrose 5Drug
Sham injection
| Study group | Role | What they receive |
|---|---|---|
| PRE-GA | Active comparator | 14 mL injection of a solution containing 0.125% bupivacaine and 2 mcg/ml sufentanil before the start of surgery and 14 ml of 5% dextrose at the end of surgery into the epidural catheter Receives: Drug: Ropivacaine-Sufentanil; Drug: Dextrose 5 |
| POST-GA | Sham comparator | 14 mL injection of 5% dextrose before the start of surgery and 14 ml of a solution containing 0.125% bupivacaine and 2 mcg/ml sufentanil at the end of surgery into the epidural catheter Receives: Drug: Ropivacaine-Sufentanil; Drug: Dextrose 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average age-adjusted MAC of sevoflurane
The average age-adjusted end- tidal minimum alveolar concentration (MAC) will be calculated by averaging the end tidal MAC required to maintain the depth of anesthesia as measured by PSI between 25-50 intra-operatively. This will be compared between the two groups.
Measured: Intraoperative measurement done at the end of anesthetic
Secondary outcomes (10)
Intraoperative heart rate
Intraoperative heart rate (in beats/minute) will be documented at 5 minute interval and compared between the two groups
Measured: Intraoperative measurement
Intraoperative opioid use
Intraoperative use of short acting opioid (in microgram/Kg) as per the study protocol will be recorded and compared between the two groups
Measured: Intraoperative measurement
Postoperative opioid use in PACU
Total amount of opioids (in mg of morphine equivalents) in the PACU and over the first 24 postoperative hours will be recorded and compared between the two groups
Measured: Up to 24 postoperative hours
Maximum pain scores in the first 24 post-operative hours
Maximum pain scores will be recorded using numerical rating scale (NRS) of 0-10 (where 0=no pain and 10= maximum pain) on arrival to PACU and at 0,15,30, 45 minutes and at 24 postoperative hours and compared between the two groups
Measured: Up to 24 postoperative hours
Nausea and vomiting in the first 24 post-operative hours
Nausea scores (on a Likert scale of 1-4 where 1 = no nausea, 2= mild nausea, 3= moderate nausea and 4= severe nausea) and incidence of vomiting will be recorded on arrival to PACU and at 0,15,30, 45 minutes and at 24 postoperative hours and will be compared between the two groups
Measured: Up to 24 postoperative hours
24 hour opioid consumption
Frequency and total consumption of opioids (in morphine equivalents) over the first 24 postoperative hours will be recorded and compared between the two groups
Measured: Up to 24 postoperative hours
The sedation score in PACU
Sedation scores will be recorded at 15 minute intervals based on Ramsay sedation scale (1-6) and will be compared between the two groups
Measured: 1st postoperative hour
Temperature testing ("Cold test")
Sensory testing of the abdominal dermatomes will be performed in the PACU at 30 minutes of arrival to PACU to document the success of the block
Measured: 1st postoperative hour
Intraoperative vasopressor usage
Amount and frequency of the intraoperative usage of vasopressor (phenylephrine in micrograms) will be documented and compared between the two groups
Measured: Intraoperative period
Intraoperative mean blood pressure
Intraoperative mean blood pressure (in mm Hg) will be documented at 5 minute interval and compared between the two groups
Measured: Intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start1 Aug 2019
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Why it stopped: Inability to enroll participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blinded, randomized controlled, prospective
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vivian HY Ip, MD, Study director, University of AlbertaLora Pencheva, MD, Study director, University of AlbertaRakesh V Sondekoppam, MD, Study chair, University of AlbertaTimur JP Özelsel, MD, DESA, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021264
- Sponsor's protocol ID
- Pro00092898
- Status last verified
- May 2022
- First submitted
- 10 Jul 2019
- Last updated
- 27 May 2022
- 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 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of an Epidural Anesthetic on the Consumption of Sevoflurane in Major Abdominal Surgery
- ClinicalTrials.gov ID
- NCT04021264
- Acronym / sponsor ID
- Pro00092898
- Keywords
- Major abdominal surgery, epidural, environmental footprint
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Inability to enroll participants.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 16 Jul 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.
Major abdominal surgery - like non-laparoscopic bowel resection, liver, gastric, or pancreas surgery - is performed under general anesthesia. Pain control for after the surgery can be achieved purely with intravenous and oral pain medication or in combination with freezing of the nerves. Nerve freezing (nerve block) placed before surgery has the potential to substantially reduce the amount of inhaled anesthetic given to the patient during surgery. This can benefit the patient with being more awake and crisp more quickly after surgery. It can also reduce cost to the system. A further benefit which has received very little attention so far, is that reducing the amount of inhaled anesthetic given also lowers the environmental footprint created by the anesthetic.
The investigators of the proposed study plan to quantify the amount of inhaled anesthetic used for each case and will compare how the consumption is affected by whether the epidural block is applied before or after surgery. Patients will have a nerve block catheter (epidural catheter) placed prior to the induction of general anesthetic by an experienced regional anesthesiologist. The epidural catheter will be bolused with a solution to which the anesthesiologist is blinded which will either be local anesthetic or dextrose (sham). The general anesthetic will be conducted according to a the protocol with the aim of maintaining a standard anesthetic depth monitored by patient state index (PSI). Measurements of the MAC-Value (minimum alveolar concentration) of inhaled anesthetic will be recorded every five minutes and will be noted down by a blinded observer. At the end of the case the anesthesiologist blinded to the solution will inject another solution (now a dextrose (sham) or local anesthetic before the patient is woken up.
Detailed description
Following ethics approval, eligible patients meeting the inclusion/exclusion criteria will be consented in pre-assessment unit or day surgery ward at least 2 hours prior to their surgery. Patients will then be randomized into two groups:
Epidural catheter insertion with 14 mL of a solution containing 0.125% bupivacaine and 2 mcg/ml sufentanil injection (Treatment group) Epidural catheter insertion with 14 mL normal saline injection (Sham group) The patient, anesthesia provider, data recorder, OR staff and Post Anaesthetic Care Unit (PACU) nurses, will be blinded at the beginning of the case. After randomization, each patient will receive a clear 20 mL syringe containing either the Treatment or the Sham solution. Prior to induction of general anesthesia, an epidural catheter will be inserted by an experienced acute pain physician who has been performing epidural blocks for at least 5 years. Catheter placement will be verified by a single test dose of 60 mg lidocaine to exclude subarachnoid tip location.
Induction of general anesthesia will follow a standardized protocol with the intravenous administration of fentanyl (2 mcg/kg), propofol (2 mg/kg), and rocuronium (0.6 mg/kg). General anesthesia will initially be maintained with sevoflurane at 1.0 age-adjusted Minimal Alveolar Concentration (MAC). Subsequently, the age-adjusted MAC will be titrated to achieve an intraoperative PSI target of 25-50 (Sedline, Masimo®), and intraoperative heart rate (HR) and mean blood pressure (MBP) target of +/-30% baseline values. The anaesthesiologist will have the ability to administer IV boluses of analgesic (remifentanil 0.5mcg/kg) at if the PSI is <50 and the MBP or HR is above 30% of baseline. Vasopressors such as phenylephrine (100 mcg IV bolus) and ephedrine (5 mg IV bolus) can be used as last-line therapy to treat hypotension that is unresponsive to MAC adjustments. The age-adjusted MAC value will be recorded every 5 minutes starting at the time of skin incision until the time of skin closure. In addition, intraoperative analgesic and vasopressor usage are recorded. The epidural catheter will be run continuously throughout the surgery with 4-6 ml/h with study drug number 1 as per randomization - so either treatment or sham. After the conclusion of MAC recording and prior to emergence from general anesthesia, the anaesthesiologist will be unblinded to the randomized groups, and the patients who received Sham solution will be given 20 mL of the treatment solution via the interscalene catheter to ensure patients receive adequate analgesia postoperatively.
Postoperatively, patients will be transported to PACU where the distribution of the sensory or motor block will then be checked and recorded 30 minutes after arriving in PACU in both groups. The NRS for pain will also be recorded in PACU at 0, 15, 30 and 45 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Double-blinded, randomized controlled, prospective
| Arm | Type | Receives |
|---|---|---|
| PRE-GA | Active comparator | Drug: Ropivacaine-Sufentanil, Drug: Dextrose 514 mL injection of a solution containing 0.125% bupivacaine and 2 mcg/ml sufentanil before the start of surgery and 14 ml of 5% dextrose at the end of surgery into the epidural catheter |
| POST-GA | Sham comparator | Drug: Ropivacaine-Sufentanil, Drug: Dextrose 514 mL injection of 5% dextrose before the start of surgery and 14 ml of a solution containing 0.125% bupivacaine and 2 mcg/ml sufentanil at the end of surgery into the epidural catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing elective reconstructive foot and ankle surgery
- Patients eligible for popliteal and saphenous nerve block
- All adults 18 years of age or older
- Capable to give consent
Key exclusion criteria (8 listed)
- Patients who are unable to give consent
- Local anaesthetic allergy
- Hemidiaphragm paresis on the contralateral side to the block/surgery site
- Bleeding diathesis
- Coagulopathy
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 |
|---|---|---|
| Ropivacaine-SufentanilLocal anesthetic injection | Drug | POST-GA, PRE-GA |
| Dextrose 5Sham injection | Drug | POST-GA, PRE-GA |
Primary outcome
Average age-adjusted MAC of sevoflurane
Time frame: Intraoperative measurement done at the end of anesthetic
The average age-adjusted end- tidal minimum alveolar concentration (MAC) will be calculated by averaging the end tidal MAC required to maintain the depth of anesthesia as measured by PSI between 25-50 intra-operatively. This will be compared between the two groups.
10 secondary outcomes
Intraoperative heart rate
Time frame: Intraoperative measurement
Intraoperative opioid use
Time frame: Intraoperative measurement
Postoperative opioid use in PACU
Time frame: Up to 24 postoperative hours
Maximum pain scores in the first 24 post-operative hours
Time frame: Up to 24 postoperative hours
Nausea and vomiting in the first 24 post-operative hours
Time frame: Up to 24 postoperative hours
24 hour opioid consumption
Time frame: Up to 24 postoperative hours
The sedation score in PACU
Time frame: 1st postoperative hour
Temperature testing ("Cold test")
Time frame: 1st postoperative hour
Intraoperative vasopressor usage
Time frame: Intraoperative period
Intraoperative mean blood pressure
Time frame: Intraoperative period
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
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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.
Vivian HY Ip, MD study director
University of Alberta
Lora Pencheva, MD study director
University of Alberta
Rakesh V Sondekoppam, MD study chair
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ropivacaine-Sufentanil and Dextrose 5 in people with Bowel Disease and Liver Diseases, run by University of Alberta at 1 site in Canada.
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 8 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: withdrawn, as of the sponsor's last update on 27 May 2022. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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?
Average age-adjusted MAC of sevoflurane (time frame: Intraoperative measurement done at the end of anesthetic). 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 27 May 2022.