An interventional study of (Epidural /GA using tolerable endotracheal tube (TET) group, group II and standard general anesthetic technique, control group, group I in Postoperative Recovery, Epidural Blockade and Endotracheal Tube, sponsored by Zagazig University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-08-18.
Sponsored by Zagazig University · Not applicable, Interventional, and Supportive care
Now, enhanced recovery after surgery (ERAS) is considered an essential goal to improve patient satisfaction, increase surgical workflow rate and facilitate performing different surgical procedures, including lumber laminectomy, on an ambulatory base. Different ERAS protocols have been applied and succeeded to improve recovery profile after colonic, rectal, gastric, urologic, biliary, pancreatic, and gynecologic procedures. Up to our knowledge, it is the 1st trial that will investigate the effect of combining single shot epidural blockade and general anesthesia (GA) using tolerable endotracheal tube (TET), as components for ERAS protocol for patients undergoing lumber laminectomy, on postoperative recovery profile. so the current study will be done to assess if Single shot epidural blockade and GA using TET, for patients undergoing lumber laminectomy, can enhance their postoperative recovery.
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:
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.
Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
standard general anesthetic (GA) technique
Procedure: standard general anesthetic technique, control group, group I
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)
Procedure: (Epidural /GA using tolerable endotracheal tube (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 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.
patients will undergo standard general anesthesia with classic endotracheal tube
Time to achievement of phase I recovery criteria
time to achievement of modified Aldrete score ≥ 9 after GA or CGEA. modified aldrete score (0- 10) higher score is better score
Time frame: 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
number of patients who will achieve a modified Aldrete score ≥ 9 before PACU admission. modified aldrete score (0- 10) higher score is better score
Time frame: immediately before postoperative patient transfer out from the operating room
Time to extubation
Time to achievement of postoperative extubation criteria (eye opening, obeying commands)
Time frame: the period of time (minutes) starting from neuromuscular reversal until endotracheal extubation. estimated period of time 15 minutes
Time to achievement of phase II recovery criteria
Time to achievement of post anesthesia discharge scoring system (PADSS) for determining home readiness ≥ 9. PADSS (0-10). higher score is better score
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
incidence of persistant coughing or agitation on emergence from GA
persistant coughing due to tracheal irritation by endotracheal tube (ETT), agitation is defined as RSS=1
Time frame: occuring after neuromuscular reversal up to 20 mins after extubation
patient's rating of perioperative satisfaction
measured on a scale from 1 to 10. higher score is better score
Time frame: immediately before hospital discharge (after the 1st postoperative 24- 48 hrs)
Time to 1st postoperative rescue analgesia
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
Time frame: period of time (minutes) from extubation time to 1st diclofenac administration. estimated period is the 1st postoperative 6 hours
Total postoperative rescue analgesic doses required to maintain VAS for pain less than 4
Total postoperative rescue nalbufen (mg)) requirements
Time frame: Total postoperative rescue nalbufen (mg)) requirements for 1st postoperative 24hrs
incidence of intraoperative complications
number of patients who will suffer either intraoperative hypotension or bradycardia
Time frame: during operative period (from anesthetic induction to tracheal extubation. estimated time 2 hours
incidence of postoperative complications
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
Time frame: from extubation to home discharge. estimated time 48 hrs
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Zagazig University