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Postoperative RecoveryNCT04981158

Enhanced Recovery After Lumber Laminectomy Using Epidural and General Anesthesia

A study testing (Epidural /GA using tolerable endotracheal tube (TET) group, group II in people with Postoperative Recovery and Epidural Blockade, run by Zagazig University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 50 years
What is being tested?
(Epidural /GA using tolerable endotracheal tube (TET) group, group II
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteEgypt
Study dates
15 Jan 2017to 20 Apr 2018
Phase
Interventional
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 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Zagazig University Hospitals

    Zagazig, Outside US, 44111

Other trials in Egypt

About this study

Official title: Enhanced Recovery After Lumber Laminectomy Using Combined Epidural and General Anesthesia With Tolerable Endotracheal Tube

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.

Read the 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:

  1. 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.
  2. Patients' satisfaction, time to Post anesthesia discharge scoring system (PADSS) for determining home readiness ≥ 9 and incidence of hospital re-admission
  3. Intra operative hemodynamic stability, blood loss, operative time and surgeon's satisfaction.
  4. 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.

Being tested
(Epidural /GA using tolerable endotracheal tube (TET) group, group II, standard general anesthetic technique, control group, group I
Keywords
enhanced recovery, epidural anesthesia, tolerable endotracheal tube, general anesthesia, laminectomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • (Epidural /GA using tolerable endotracheal tube (TET) group, group IIProcedure or surgery

    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.

  • standard general anesthetic technique, control group, group IProcedure or surgery

    patients will undergo standard general anesthesia with classic endotracheal tube

Study groups in NCT04981158
Study groupRoleWhat they receive
control group, group IPlacebo comparatorstandard general anesthetic (GA) technique
Receives: Procedure: standard general anesthetic technique, control group, group I
Epidural /GA using TET group, group IIActive comparatorpatients 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)
Receives: Procedure: (Epidural /GA using tolerable endotracheal tube (TET) group, group II

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: the period of time (mins) starting from extubation to achievement of modified Aldrete score ≥ 9. estimated period of time 30 minutes

  2. 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

    Measured: immediately before postoperative patient transfer out from the operating room

Secondary outcomes (4)

  1. Time to extubation

    Time to achievement of postoperative extubation criteria (eye opening, obeying commands)

    Measured: the period of time (minutes) starting from neuromuscular reversal until endotracheal extubation. estimated period of time 15 minutes

  2. 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

    Measured: 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

  3. 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

    Measured: occuring after neuromuscular reversal up to 20 mins after extubation

  4. patient's rating of perioperative satisfaction

    measured on a scale from 1 to 10. higher score is better score

    Measured: immediately before hospital discharge (after the 1st postoperative 24- 48 hrs)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2021
  2. Study start15 Jan 2017
  3. Primary completion12 Dec 2017
  4. Study completion20 Apr 2018

Resources

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 N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04981158
Sponsor's protocol ID
ZU-IRB #3225-18-12-2016
Status last verified
Aug 2023
First submitted
26 Jun 2021
Last updated
18 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing (Epidural /GA using tolerable endotracheal tube (TET) group, group II in people with Postoperative Recovery and Epidural Blockade, run by Zagazig University at 1 site in Egypt.

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 3 inclusion and 12 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: finished, as of the sponsor's last update on 18 Aug 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 Egypt. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04981158.

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 18 Aug 2023.

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