Anesthesia Clinical Trial
— RUMBLEOfficial 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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | August 1, 2024 |
Est. primary completion date | July 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age > 18, American Society of Anesthesiology (ASA) class I-III patients scheduled for elective laparoscopic/laparoscopic assisted colorectal surgery Exclusion Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
Canada | Royal University Hospital | Saskatoon | Saskatchewan |
Lead Sponsor | Collaborator |
---|---|
University of Saskatchewan |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to first flatus | Time between the end of surgery and the movement when the patient first passes flatus | End of surgery to first flatus (1-4 days) | |
Secondary | Time to first defecation | Time between the end of surgery and the moment the patient first passes stool | End of surgery to first defecation (1-7 days) | |
Secondary | Time to tolerance of oral intake | Time between the end of surgery to when the patient can tolerate any oral solid food intake | End of surgery to first oral intake (1-3 days) | |
Secondary | Total Post-Anesthetic Care Unit (PACU) opioid consumption | Total amount of opioid (morphine equivalents) required in PACU | End of surgery to discharge from PACU (1-2 hours) | |
Secondary | Patient Controlled Analgesia (PCA) morphine consumption | Total amount of PCA morphine (mg) required from end of surgery to 48 hours postoperatively | End of surgery to 48 hours postoperatively | |
Secondary | Time to Post-Anesthetic Care Unit (PACU) discharge readiness | Time to Post-Anesthetic Care Unit (PACU) discharge readiness | End of surgery to PACU discharge readiness (1-3 hours) | |
Secondary | 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 | End of surgery to 48 hours postoperatively | |
Secondary | 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 | End of surgery to time of patient discharge from hospital (2-10 days) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04279054 -
Decreased Neuraxial Morphine After Cesarean Delivery
|
Early Phase 1 | |
Active, not recruiting |
NCT04580030 -
Tricuapid Annular Plane Sistolic Excursion Before General Anesthesia Can Predict Hypotension After Induction
|
||
Completed |
NCT03640442 -
Modified Ramped Position for Intubation of Obese Females.
|
N/A | |
Recruiting |
NCT04099693 -
A Prospective Randomized Study of General Anesthesia Versus Anesthetist Administered Sedation for ERCP
|
||
Terminated |
NCT02481999 -
Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
|
||
Completed |
NCT04235894 -
An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia
|
||
Recruiting |
NCT05525104 -
The Effect of DSA on Recovery of Anaesthesia in Children (Het Effect Van DSA op Het Herstel na Anesthesie Bij Kinderen).
|
N/A | |
Recruiting |
NCT05024084 -
Desflurane and Sevoflurane Minimal Flow Anesthesia on Recovery and Anesthetic Depth
|
Phase 4 | |
Completed |
NCT04204785 -
Noise in the OR at Induction: Patient and Anesthesiologists Perceptions
|
N/A | |
Completed |
NCT03277872 -
NoL, HR and MABP Responses to Tracheal Intubation Performed With MAC Blade Versus Glidescope
|
N/A | |
Terminated |
NCT03940651 -
Cardiac and Renal Biomarkers in Arthroplasty Surgery
|
Phase 4 | |
Terminated |
NCT02529696 -
Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers
|
||
Completed |
NCT05346588 -
THRIVE Feasibility Trial
|
Phase 3 | |
Terminated |
NCT03704285 -
Development of pk/pd Model of Propofol in Patients With Severe Burns
|
||
Recruiting |
NCT05259787 -
EP Intravenous Anesthesia in Hysteroscopy
|
Phase 4 | |
Completed |
NCT02894996 -
Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Pediatric Patient?
|
N/A | |
Completed |
NCT05386082 -
Anesthesia Core Quality Metrics Consensus Delphi Study
|
||
Terminated |
NCT03567928 -
Laryngeal Mask in Upper Gastrointestinal Procedures
|
N/A | |
Recruiting |
NCT06074471 -
Motor Sparing Supraclavicular Block
|
N/A | |
Completed |
NCT04163848 -
CARbon Impact of aNesthesic Gas
|