AnesthesiaPhase 3RUMBLENCT04144933
Effect of Multimodal Opioid-free Anesthesia on Return of Bowel Function in Laparoscopic Colorectal Surgery
A Phase 3 study testing Acetaminophen, Gabapentin, Lidocaine 1% Injectable Solution, Dexmedetomidine, Ketamine and Dexamethasone, Ondansetron in people with Anesthesia and General Anesthesia, run by University of Saskatchewan at 1 site in Canada.
Trial summary
The objective of this study is to determine if an opioid-free general anesthetic (OFA) technique utilizing lidocaine, ketamine, dexmedetomidine and magnesium reduce postoperative opioid consumption and speed return of bowel function in patients undergoing elective, laparoscopic, colorectal surgery compared to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, General Anesthesia, Analgesics, Opioid
- What is being tested?
- Acetaminophen, Gabapentin, Lidocaine 1% Injectable Solution, Dexmedetomidine, Ketamine and Dexamethasone, Ondansetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 15 May 2021to 1 Aug 2024
- Phase
- Phase 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18, American Society of Anesthesiology (ASA) class I-III patients scheduled for elective laparoscopic/laparoscopic assisted colorectal surgery
Who cannot join
- Emergency surgery, open surgery, contraindications to laparoscopic surgery (ie. adhesions, inability to tolerate pneumoperitoneum), American Society of Anesthesiology (ASA) class 4, age < 18, pregnant or breastfeeding women, significant cardiorespiratory/hepatic/renal disease, allergy to any study drugs, inability to consent, inability to respond to pain assessments, inability to use the patient controlled analgesia device (PCA)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8
Jennifer O'Brien, PhD, 306-655-6497, jennifer.o'brien@saskatoonhealthregion.ca
About this study
Official title: A Randomized Control Trial Evaluating the Utility of Multimodal Opioid-free Anesthesia on Return of Bowel Function in Laparoscopic Colorectal Surgery
The objective of this study is to determine if an opioid-free general anesthetic (OFA) technique utilizing lidocaine, ketamine, dexmedetomidine and magnesium reduce postoperative opioid consumption and speed return of bowel function in patients undergoing elective, laparoscopic, colorectal surgery compared to traditional opioid-containing general anesthetic techniques. It is hypothesized that this intraoperative OFA regimen will reduce postoperative opioid consumption, and expedite return of bowel function in this population.
Read the detailed description
The objective of this trial is to determine whether an opioid-free general anesthetic can help reduce postoperative opioid consumption and speed return of bowel function in patients undergoing elective, laparoscopic, colorectal surgery when compared with traditional opioid-containing techniques.
- Conditions
- Anesthesia, General Anesthesia, Analgesics, Opioid, Opioid Free Anesthesia, Postoperative Ileus, Colorectal Surgery
- Being tested
- Acetaminophen, Gabapentin, Lidocaine 1% Injectable Solution, Dexmedetomidine, Ketamine, Dexamethasone, Ondansetron, Sevoflurane, Lidocaine 2% Injectable Solution, Ketamine, Dexmedetomidine, Magnesium Sulfate, Lidocaine 1% Injectable Solution, Sufentanil
- Keywords
- Opioid-free, Opioid-sparing
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetaminophen, GabapentinDrug
Also called Opioid-free preoperative medications
975 mg, 300 mg
Acetaminophen, GabapentinDrug
Also called Opioid-containing preoperative medications
975 mg, 300 mg
Lidocaine 1% Injectable Solution, Dexmedetomidine, KetamineDrug
Also called Opioid-free pre-intubation medications
1.5 mg/kg, 0.5 mcg/kg, 0.5 mg/kg
Dexamethasone, OndansetronDrug
Also called Postoperative nausea and vomiting prophylaxis
6 mg, 4 mg
Sevoflurane, Lidocaine 2% Injectable Solution, Ketamine, Dexmedetomidine, Magnesium SulfateDrug
Also called Opioid-free maintenance medications
Dose titrated to effect, 1.5 mg/kg/hr, 0.15 mg/kg/hr, 0.3 -1 mcg/kg/hr (titrated to effect), 30 mg/kg bolus over 30 minutes
Lidocaine 1% Injectable Solution, SufentanilDrug
Also called Opioid-containing pre-intubation medications
0.5 mg/kg, 0.25-0.5 mcg/kg (titrated to effect)
Sevoflurane, SufentanilDrug
Also called Opioid-containing maintenance medications
Dose titrated to effect, As needed (dose at anesthesiologist's discretion)
| Study group | Role | What they receive |
|---|---|---|
| Opioid-free General Anesthesia (OFA) | Experimental | Opioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis. Receives: Drug: Acetaminophen, Gabapentin; Drug: Lidocaine 1% Injectable Solution, Dexmedetomidine, Ketamine; Drug: Dexamethasone, Ondansetron; Drug: Sevoflurane, Lidocaine 2% Injectable Solution, Ketamine, Dexmedetomidine, Magnesium Sulfate |
| Traditional Opioid-containing General Anesthesia (TOA) | Active comparator | Opioid-sparing preoperative medications, Opioid-containing pre-intubation medications, Opioid-containing maintenance medications, postoperative nausea and vomiting prophylaxis. Receives: Drug: Acetaminophen, Gabapentin; Drug: Dexamethasone, Ondansetron; Drug: Lidocaine 1% Injectable Solution, Sufentanil; Drug: Sevoflurane, Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first flatus
Time between the end of surgery and the movement when the patient first passes flatus
Measured: End of surgery to first flatus (1-4 days)
Secondary outcomes (7)
Time to first defecation
Time between the end of surgery and the moment the patient first passes stool
Measured: End of surgery to first defecation (1-7 days)
Time to tolerance of oral intake
Time between the end of surgery to when the patient can tolerate any oral solid food intake
Measured: End of surgery to first oral intake (1-3 days)
Total Post-Anesthetic Care Unit (PACU) opioid consumption
Total amount of opioid (morphine equivalents) required in PACU
Measured: End of surgery to discharge from PACU (1-2 hours)
Patient Controlled Analgesia (PCA) morphine consumption
Total amount of PCA morphine (mg) required from end of surgery to 48 hours postoperatively
Measured: End of surgery to 48 hours postoperatively
Time to Post-Anesthetic Care Unit (PACU) discharge readiness
Time to Post-Anesthetic Care Unit (PACU) discharge readiness
Measured: End of surgery to PACU discharge readiness (1-3 hours)
Visual Analogue Scale (VAS) pain scores
Visual Analogue Scale (VAS) pain scores will be recorded on a scale of 0 to 10, with 0 indicating no pain, and 10 indicating extreme pain, 48 hours following surgery
Measured: End of surgery to 48 hours postoperatively
Quality of recovery after surgery
Assessed using the Quality of Recovery (QoR) 15 questionnaire, a validated tool for measuring quality of recovery after anesthesia and surgery
Measured: End of surgery to time of patient discharge from hospital (2-10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start15 May 2021
- Primary completion30 Jul 2024 (estimated)
- Study completion1 Aug 2024 (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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Gamble, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144933
- Sponsor's protocol ID
- BIO-625
- Acronym
- RUMBLE
- Status last verified
- Dec 2023
- First submitted
- 25 Oct 2019
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial Evaluating the Utility of Multimodal Opioid-free Anesthesia on Return of Bowel Function in Laparoscopic Colorectal Surgery
- ClinicalTrials.gov ID
- NCT04144933
- Acronym / sponsor ID
- RUMBLE / BIO-625
- Conditions
- Anesthesia, General Anesthesia, Analgesics, Opioid, Opioid Free Anesthesia, Postoperative Ileus, Colorectal Surgery
- Keywords
- Opioid-free, Opioid-sparing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 30 Oct 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.
The objective of this study is to determine if an opioid-free general anesthetic (OFA) technique utilizing lidocaine, ketamine, dexmedetomidine and magnesium reduce postoperative opioid consumption and speed return of bowel function in patients undergoing elective, laparoscopic, colorectal surgery compared to traditional opioid-containing general anesthetic techniques. It is hypothesized that this intraoperative OFA regimen will reduce postoperative opioid consumption, and expedite return of bowel function in this population.
Detailed description
The objective of this trial is to determine whether an opioid-free general anesthetic can help reduce postoperative opioid consumption and speed return of bowel function in patients undergoing elective, laparoscopic, colorectal surgery when compared with traditional opioid-containing techniques.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid-free General Anesthesia (OFA) | Experimental | Drug: Acetaminophen, Gabapentin, Drug: Lidocaine 1% Injectable Solution, Dexmedetomidine, Ketamine, Drug: Dexamethasone, Ondansetron, Drug: Sevoflurane, Lidocaine 2% Injectable Solution, Ketamine, Dexmedetomidine, Magnesium SulfateOpioid-free preoperative medications, Opioid-free pre-intubation medications, Opioid-free maintenance medication, postoperative nausea and vomiting prophylaxis. |
| Traditional Opioid-containing General Anesthesia (TOA) | Active comparator | Drug: Acetaminophen, Gabapentin, Drug: Dexamethasone, Ondansetron, Drug: Lidocaine 1% Injectable Solution, Sufentanil, Drug: Sevoflurane, SufentanilOpioid-sparing preoperative medications, Opioid-containing pre-intubation medications, Opioid-containing maintenance medications, postoperative nausea and vomiting prophylaxis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age > 18, American Society of Anesthesiology (ASA) class I-III patients scheduled for elective laparoscopic/laparoscopic assisted colorectal surgery
Key exclusion criteria (1 listed)
- Emergency surgery, open surgery, contraindications to laparoscopic surgery (ie. adhesions, inability to tolerate pneumoperitoneum), American Society of Anesthesiology (ASA) class 4, age < 18, pregnant or breastfeeding women, significant cardiorespiratory/hepatic/renal disease, allergy to any study drugs, inability to consent, inability to respond to pain assessments, inability to use the patient controlled analgesia device (PCA)
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 |
|---|---|---|
| Acetaminophen, GabapentinAlso: Opioid-free preoperative medications975 mg, 300 mg | Drug | Opioid-free General Anesthesia (OFA) |
| Acetaminophen, GabapentinAlso: Opioid-containing preoperative medications975 mg, 300 mg | Drug | Traditional Opioid-containing General Anesthesia (TOA) |
| Lidocaine 1% Injectable Solution, Dexmedetomidine, KetamineAlso: Opioid-free pre-intubation medications1.5 mg/kg, 0.5 mcg/kg, 0.5 mg/kg | Drug | Opioid-free General Anesthesia (OFA) |
| Dexamethasone, OndansetronAlso: Postoperative nausea and vomiting prophylaxis6 mg, 4 mg | Drug | Opioid-free General Anesthesia (OFA), Traditional Opioid-containing General Anesthesia (TOA) |
| Sevoflurane, Lidocaine 2% Injectable Solution, Ketamine, Dexmedetomidine, Magnesium SulfateAlso: Opioid-free maintenance medicationsDose titrated to effect, 1.5 mg/kg/hr, 0.15 mg/kg/hr, 0.3 -1 mcg/kg/hr (titrated to effect), 30 mg/kg bolus over 30 minutes | Drug | Opioid-free General Anesthesia (OFA) |
| Lidocaine 1% Injectable Solution, SufentanilAlso: Opioid-containing pre-intubation medications0.5 mg/kg, 0.25-0.5 mcg/kg (titrated to effect) | Drug | Traditional Opioid-containing General Anesthesia (TOA) |
| Sevoflurane, SufentanilAlso: Opioid-containing maintenance medicationsDose titrated to effect, As needed (dose at anesthesiologist's discretion) | Drug | Traditional Opioid-containing General Anesthesia (TOA) |
Primary outcome
Time to first flatus
Time frame: End of surgery to first flatus (1-4 days)
Time between the end of surgery and the movement when the patient first passes flatus
7 secondary outcomes
Time to first defecation
Time frame: End of surgery to first defecation (1-7 days)
Time to tolerance of oral intake
Time frame: End of surgery to first oral intake (1-3 days)
Total Post-Anesthetic Care Unit (PACU) opioid consumption
Time frame: End of surgery to discharge from PACU (1-2 hours)
Patient Controlled Analgesia (PCA) morphine consumption
Time frame: End of surgery to 48 hours postoperatively
Time to Post-Anesthetic Care Unit (PACU) discharge readiness
Time frame: End of surgery to PACU discharge readiness (1-3 hours)
Visual Analogue Scale (VAS) pain scores
Time frame: End of surgery to 48 hours postoperatively
Quality of recovery after surgery
Time frame: End of surgery to time of patient discharge from hospital (2-10 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: No
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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 Phase 3 study testing Acetaminophen, Gabapentin, Lidocaine 1% Injectable Solution, Dexmedetomidine, Ketamine and Dexamethasone, Ondansetron in people with Anesthesia and General Anesthesia, run by University of Saskatchewan 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 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: status not confirmed, as of the sponsor's last update on 20 Dec 2023. 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. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Gamble, MD (306-655-1183, jonathan.gamble@saskhealthauthority.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first flatus (time frame: End of surgery to first flatus (1-4 days)). 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 20 Dec 2023.