- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04981158
Enhanced Recovery After Lumber Laminectomy Using Epidural and General Anesthesia
Enhanced Recovery After Lumber Laminectomy Using Combined Epidural and General Anesthesia With Tolerable Endotracheal Tube
Study Overview
Status
Detailed Description
The study will be carried out at anesthesia and surgical intensive care department -Zagazig University Hospitals. Patients of both sexes, assigned to a single or double level lumbar laminectomy or discectomy, will be included in the study. all patients will be preoperatively evaluated according to standard local protocol. patients, who will not be excluded, will be assigned to one of two groups: Group I (control group) patients who will undergo standard general anesthetic technique and Group II (combined general/ epidural anesthesia group (CGEA)) patients will undergo single shot epidural analgesia [by bupivacaine (15 ml with 0.25% concentration)] followed by induction of standard general anesthesia (GA) using tolerable endotracheal tube (TET)
Both groups will be compared as regard:
- Patient recovery in the form of time to extubation, , time to achieving modified aldrete score ≥ 9 , duration of post-anesthesia care unit (PACU) stay and incidence of PACU bypass.
- Patients' satisfaction, time to Post anesthesia discharge scoring system (PADSS) for determining home readiness ≥ 9 and incidence of hospital re-admission
- Intra operative hemodynamic stability, blood loss, operative time and surgeon's satisfaction.
- Postoperative pain scores and analgesic requirements.
Sample size was calculated using Epi Info 6, based on expected time to modified Aldrete score ≥ 9 in group I 13.1± 3.7 in group GA and in group II 7.9 ± 3.2 , confidence interval 95% and power of test 80%, to be 32. Eight patients will be added to compensate for dropout, so the total number of patients will be 40 patients.
All data will be collected, tabulated and statistically analyzed using SPSS 20.0 for windows (SPSS Inc., Chicago, IL, USA) and MedCalc 13 for windows (MedCalc Software bvba, Ostend, Belgium). According to the type of data qualitative data will be represented as number and percentage, parametric quantitative data will be represented by mean ± standard deviation (SD), non-parametric data will be presented as median and range and the following tests were used to test differences for significance and association of qualitative variable by Chi square test (X2). Differences between quantitative multiple by student t-test or Mann Whitney test as appropriate. P value was set at <0.05 for significant results.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Outside US
-
Zagazig, Outside US, Egypt, 44111
- Zagazig University Hospitals
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- American society of anesthesiologists (ASA) grade I-II
- body mass index (BMI) < 30 kg/m2
- assignment to a single or double level lumbar laminectomy or discectomy
Exclusion Criteria:
- Patient's refusal of the procedure
- local infection at site of catheter insertion
- recurrent disc surgery, emergency surgery
- coagulopathies
- hemoglobin <8 g/dl
- history of stroke or psychiatric disease
- baseline neurological deficit
- active upper respiratory tract infections
- history of either laryngeal / tracheal surgery or pathology
- uncontrolled hypertension or diabetes mellitus (DM), cardiac, pulmonary, hepatic or renal dysfunction
- any contraindication for study technique or medications
- being on regular steroids, opioid analgesics or alpha 2 agonists.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: control group, group I
standard general anesthetic (GA) technique
|
patients will undergo standard general anesthesia with classic endotracheal tube
|
Active Comparator: Epidural /GA using TET group, group II
patients will undergo a single shot epidural bupivacaine (15 ml with 0.25% concentration) followed by a standard general anesthetic technique in which the trachea was intubated using tolerable endotracheal tube (TET)
|
patients will undergo a single shot epidural bupivacaine (15 ml with 0.25% concentration) followed by a standard general anesthetic technique in which the trachea was intubated using TET, through its side port 2mg/kg , lidocaine 2% will be sprayed immediately after intubation when the patient is in flat supine position then the same dose of lidocaine will be repeated 10 minutes before anesthetic discontinuation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to achievement of phase I recovery criteria
Time Frame: the period of time (mins) starting from extubation to achievement of modified Aldrete score ≥ 9. estimated period of time 30 minutes
|
time to achievement of modified Aldrete score ≥ 9 after GA or CGEA.
modified aldrete score (0- 10) higher score is better score
|
the period of time (mins) starting from extubation to achievement of modified Aldrete score ≥ 9. estimated period of time 30 minutes
|
incidence of successful PACU bypass
Time Frame: immediately before postoperative patient transfer out from the operating room
|
number of patients who will achieve a modified Aldrete score ≥ 9 before PACU admission.
modified aldrete score (0- 10) higher score is better score
|
immediately before postoperative patient transfer out from the operating room
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to extubation
Time Frame: the period of time (minutes) starting from neuromuscular reversal until endotracheal extubation. estimated period of time 15 minutes
|
Time to achievement of postoperative extubation criteria (eye opening, obeying commands)
|
the period of time (minutes) starting from neuromuscular reversal until endotracheal extubation. estimated period of time 15 minutes
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Time to achievement of phase II recovery criteria
Time Frame: the period of time (hours) starting from endotracheal extubation to achievement of post anesthesia discharge scoring system (PADSS) for determining home readiness ≥ 9. estimated period of time 48 hours
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Time to achievement of post anesthesia discharge scoring system (PADSS) for determining home readiness ≥ 9. PADSS (0-10).
higher score is better score
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the period of time (hours) starting from endotracheal extubation to achievement of post anesthesia discharge scoring system (PADSS) for determining home readiness ≥ 9. estimated period of time 48 hours
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incidence of persistant coughing or agitation on emergence from GA
Time Frame: occuring after neuromuscular reversal up to 20 mins after extubation
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persistant coughing due to tracheal irritation by endotracheal tube (ETT), agitation is defined as RSS=1
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occuring after neuromuscular reversal up to 20 mins after extubation
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patient's rating of perioperative satisfaction
Time Frame: immediately before hospital discharge (after the 1st postoperative 24- 48 hrs)
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measured on a scale from 1 to 10. higher score is better score
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immediately before hospital discharge (after the 1st postoperative 24- 48 hrs)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to 1st postoperative rescue analgesia
Time Frame: period of time (minutes) from extubation time to 1st diclofenac administration. estimated period is the 1st postoperative 6 hours
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time to 1st achievement of moderate to severe pain visual analogue score for pain (VAS)≥ 0.4.
VAS for pain (0- 10).
lower scores indicate better pain control
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period of time (minutes) from extubation time to 1st diclofenac administration. estimated period is the 1st postoperative 6 hours
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Total postoperative rescue analgesic doses required to maintain VAS for pain less than 4
Time Frame: Total postoperative rescue nalbufen (mg)) requirements for 1st postoperative 24hrs
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Total postoperative rescue nalbufen (mg)) requirements
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Total postoperative rescue nalbufen (mg)) requirements for 1st postoperative 24hrs
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incidence of intraoperative complications
Time Frame: during operative period (from anesthetic induction to tracheal extubation. estimated time 2 hours
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number of patients who will suffer either intraoperative hypotension or bradycardia
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during operative period (from anesthetic induction to tracheal extubation. estimated time 2 hours
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incidence of postoperative complications
Time Frame: from extubation to home discharge. estimated time 48 hrs
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number of patients who will suffer postoperative hypotension, bradycardia, excessive sedation (RSS RSS≥ 5), new neurological deficit, postoperative nausea and vomiting (PONV) or urine retention
|
from extubation to home discharge. estimated time 48 hrs
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: tarek Y Gaafar, MD, Zagazig University
- Principal Investigator: abeer M elnakera, MD, Zagazig University
- Study Director: abeer H alsawy, Zagazig University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZU-IRB #3225-18-12-2016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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