Lumbar Disc DiseaseNCT04301232
Fast-Track Eligibility and Hospital Discharge for Outpatient Lumbar Discectomy
An observational study of Lumbar Disc Disease and Post-Op Complication, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial summary
122 ASA I-II patients were enrolled into the study. IV propofol, fentanyl and rocuronium were used for the induction and a total intravenous anesthesia technique for the maintenance of anesthesia. Sugammadex was given for neuromuscular blockade reversal. A multi-modal analgesic regimen was utilized. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbar Disc Disease, Post-Op Complication
- What is being tested?
- Modified Aldrete Scoring System (mASS), White's Fast-Track Scoring System (WFTSS) and SPEEDS criteria
- How many people
- 122 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2018to 28 Jan 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 122 ASA (American Society of Anesthesiologists) physical status I-II patients, aged between 18-65 years, undergoing elective lumbar discectomy under general anesthesia were included into the study.
Who may be able to join
- ASA (American Society of Anesthesiologists) physical status I-II patients
- elective primary lumbar discectomy performed for one or two vertebra levels under general anesthesia
- minimal risks for perioperative bleeding and airway safety
Who cannot join
- patient's refusal
- urgent surgery,
- regional anesthesia,
- history of previous lumbar surgery
- difficult ventilation and intubation,
- treatment for chronic pain
Show all 9Show fewer
- obstructive sleep apnea,
- morbid obesity (BMI≥40 kg/m2)
- allergy to drugs
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Çankaya Hospital, Department of Anesthesiology and Reanimation, Ankara, Turkey
Ankara, Çankaya/ANKARA, 06010
About this study
Official title: Fast-Track Eligibility and Hospital Discharge for Outpatient Lumbar Discectomy: A Prospective Observational Study
122 ASA I-II patients were enrolled into the study. IV propofol, fentanyl and rocuronium were used for the induction and a total intravenous anesthesia technique for the maintenance of anesthesia. Sugammadex was given for neuromuscular blockade reversal. A multi-modal analgesic regimen was utilized. Primary outcome measures were PACU bypass rates and hospital discharge times. Secondary outcome measure was to compare discharge scoring systems for PACU bypass assessment: modified Aldrete Scoring System (mASS), White's Fast-Tracking Scoring System (WFTSS), and SPEEDS criteria
Read the detailed description
After obtaining hospital's ethics committee approval (University of Medical Sciences, Gülhane Training and Research Hospital- Date: 06/05/2018; No: 18/148) and written informed consents obtained from patients, 122 ASA (American Society of Anesthesiologists) physical status I-II patients, aged between 18-65 years, undergoing elective lumbar discectomy under general anesthesia were included into the study . After anesthesia application applied to all groups with the same procedure, patients were extubated after surgery. After extubation, patients were evaluated using mASS, WFTSS and SPEEDS criteria during 15 minutes with 3 min intervals. Patients who fulfilled criteria of all scoring systems were defined as eligible for PACU by-pass (fast-tracking) and transferred into phase II recovery area in the ward without observation in PACU (Group FT = Fast Track;). Ineligible patients were taken into PACU where their treatments were continued until discharge criteria were achieved (Group PACU). All patients were followed in the ward until hospital discharge. IV tramadol PCA (Patient -Controlled Analgesia; infusion rate: 4 mgh-1, bolus dose: 4mg, lock-out time: 30 min., 4 hours-limit: 30 mg), paracetamol (10 mgkg-1 IV with 6 hrs. intervals) and oral diclofenac sodium (75 mg with 8 hrs. intervals) were given in a multimodal analgesic regimen. Pain was evaluated using Visual Analogue Scale (VAS) with 2 hours intervals and IV pethidine 0.5 mgkg-1 was given as rescue analgesic throughout the study period when VAS was >3. PONV was treated using IV 4 mg ondansetron. Discharge from hospital was evaluated using Post Anesthetic Discharge Scoring System (PADSS), . Patients with a PADSS score ≥ 9 were discharged from the hospital by the escort of their relatives.
- Conditions
- Lumbar Disc Disease, Post-Op Complication
- Being tested
- Modified Aldrete Scoring System (mASS), White's Fast-Track Scoring System (WFTSS), SPEEDS criteria
- Keywords
- PACU-bypass, hospital discharge, lumbar discectomy
- Medical subject headings
- Intervertebral disc disease, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Aldrete Scoring System (mASS)Other
Activity( Moves all extremities, Moves two extremities, Unable to move extremities), Respiration( Breathes deeply, coughs freely, Dyspneic, shallow or limited breathing, Apneic), Circulation (blood pressure) ( 20 mm Hg > preanesthetic level, 20 - 50 mm Hg > preanesthetic level, 50 mm Hg > preanesthetic level), Consciousness (Fully awake, Arousable on calling, Not responding), Oxygen saturation( SpO2 > 92% on room air, Supplemental O2 required to maintain SpO2 > 90%,SpO2 < 90% with O2 supplementation), scoring is done as 2,1,0, respectively. A score of 9 or more would be required for a patient after general anesthesia for discharge
White's Fast-Track Scoring System (WFTSS)Other
Physical activity (Able to move all extremities on command, ,Some weakness in movement of extremities, Unable to voluntarily move extremities),Respiratory stability(Able to breathe deeply,Tachypnea,Dyspneic),Hemodynamic stability; (Blood pressure(MAP)<15%, Blood pressure 15-30%, Blood pressure>30%, Level of consciousness,(Awake\&orientated Arousable with minimal stimulation, Responsive only to tactile stimulation),Oxygen saturation status(Maintains value>90% on room air, Requires supplemental oxygen, Saturation<90% with supplemental oxygen), Postoperative pain assessment(None or mild discomfort, Moderate to severe pain controlled with analgesics, Persistent severe pain), Postoperative emetic symptoms(None or mild nausea w/no active vomiting, Transient vomiting or retching, Persistent moderate to severe nausea\&vomiting), Scoring is done as 2,1,0, respectively. A minimal score of 12(with no score<1 in any individual category)would be required for a patient after general anesthesia
SPEEDS criteriaOther
Extremity movement (moves all four) Y/N, Stable vital signs( SBP > 90 and < 180, HR > 50 and < 110) Y/N, Dialogue (oriented person/place) Y/N, Oxygen saturation >90% in roExtremity movement (moves all four) Y/N, Stable vital signs( SBP > 90 and < 180, HR > 50 and < 110) Y/N, Dialogue (oriented person/place) Y/N, Oxygen saturation >90% in room air Y/N, Pain Control (VAS < 4) Y/N, Emesis Control Y/N. A patient must have a response of "yes" to all parameters to progress to phase II recovery
| Study group | Role | What they receive |
|---|---|---|
| Fast-Track Group | After extubation, patients were evaluated using modified Aldrete Scoring System (mASS) , White's Fast- Track Scoring System (WFTSS) and SPEEDS criteria during 15 minutes with 3 min intervals. Patients who fulfilled criteria of all scoring systems were defined as eligible for PACU by-pass (fast-tracking) and transferred into phase II recovery area in the ward without observation in PACU (Group FT = Fast Track;) Receives: Other: Modified Aldrete Scoring System (mASS); Other: White's Fast-Track Scoring System (WFTSS); Other: SPEEDS criteria | |
| PACU Group | After extubation, patients were evaluated using modified Aldrete Scoring System (mASS) , White's Fast- Track Scoring System (WFTSS) and SPEEDS criteria during 15 minutes with 3 min intervals. Ineligible patients were taken into PACU where their treatments were continued until discharge criteria were achieved (Group PACU) Receives: Other: Modified Aldrete Scoring System (mASS); Other: White's Fast-Track Scoring System (WFTSS); Other: SPEEDS criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of the surgery
the period (minutes) from the beginning of the surgery to the end of surgery
Measured: at the end of the surgery
time to extubation
the period (minutes) from the end of surgery until extubation
Measured: 1 hour after extubation
PACU( post-anesthesia care unit) by-pass rate
The period (minutes) from admission to post-anesthesia care unit to discharge from the clinic
Measured: 1 weeks after discharge from the hospital
Time to hospital discharge
The period (hours) from hospital admission to hospital discharge.
Measured: 1 weeks after discharge from the hospital
Time to PACU by-pass in group FT
time(minutes) to be eligible for PACU by-pass in group FT according to scoring systems
Measured: 1 weeks after discharge from the hospital
time to PACU care in group PACU
duration (minutes) of PACU care for patients in group PACU
Measured: 1 weeks after discharge from the hospital
patients who were eligible for fast-tracking
number patients who were eligible for fast-tracking
Measured: through study completion, an average of 2 weeks
patients who were discharged from hospital
number patients who were discharged from hospital with respect to outpatient surgery (discharge time < 24 hours)
Measured: through study completion, an average of 2 weeks
factors preventing
factors preventing fast-tracking and/or discharge from hospital in outpatient setting
Measured: through study completion, an average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start10 May 2018
- Primary completion12 Dec 2019
- Study completion28 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 122 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Burak Eşkin, Gulhane School of Medicine
- Investigators
- Mehmet Ö ÖZHAN, M.D., Study director, Çankaya Hospital, Department of Anesthesiology and Reanimation, Ankara, TurkeyMehmet B. EŞKİN, M.D., Principal investigator, Gulhane Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301232
- Sponsor's protocol ID
- 18/148
- Status last verified
- Mar 2020
- First submitted
- 4 Mar 2020
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast-Track Eligibility and Hospital Discharge for Outpatient Lumbar Discectomy: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04301232
- Acronym / sponsor ID
- 18/148
- Conditions
- Lumbar Disc Disease, Post-Op Complication
- Keywords
- PACU-bypass, hospital discharge, lumbar discectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- 10 May 2018 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 28 Jan 2020 (actual)
- First posted
- 10 Mar 2020 (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.
122 ASA I-II patients were enrolled into the study. IV propofol, fentanyl and rocuronium were used for the induction and a total intravenous anesthesia technique for the maintenance of anesthesia. Sugammadex was given for neuromuscular blockade reversal. A multi-modal analgesic regimen was utilized. Primary outcome measures were PACU bypass rates and hospital discharge times. Secondary outcome measure was to compare discharge scoring systems for PACU bypass assessment: modified Aldrete Scoring System (mASS), White's Fast-Tracking Scoring System (WFTSS), and SPEEDS criteria
Detailed description
After obtaining hospital's ethics committee approval (University of Medical Sciences, Gülhane Training and Research Hospital- Date: 06/05/2018; No: 18/148) and written informed consents obtained from patients, 122 ASA (American Society of Anesthesiologists) physical status I-II patients, aged between 18-65 years, undergoing elective lumbar discectomy under general anesthesia were included into the study . After anesthesia application applied to all groups with the same procedure, patients were extubated after surgery. After extubation, patients were evaluated using mASS, WFTSS and SPEEDS criteria during 15 minutes with 3 min intervals. Patients who fulfilled criteria of all scoring systems were defined as eligible for PACU by-pass (fast-tracking) and transferred into phase II recovery area in the ward without observation in PACU (Group FT = Fast Track;). Ineligible patients were taken into PACU where their treatments were continued until discharge criteria were achieved (Group PACU). All patients were followed in the ward until hospital discharge. IV tramadol PCA (Patient -Controlled Analgesia; infusion rate: 4 mgh-1, bolus dose: 4mg, lock-out time: 30 min., 4 hours-limit: 30 mg), paracetamol (10 mgkg-1 IV with 6 hrs. intervals) and oral diclofenac sodium (75 mg with 8 hrs. intervals) were given in a multimodal analgesic regimen. Pain was evaluated using Visual Analogue Scale (VAS) with 2 hours intervals and IV pethidine 0.5 mgkg-1 was given as rescue analgesic throughout the study period when VAS was >3. PONV was treated using IV 4 mg ondansetron. Discharge from hospital was evaluated using Post Anesthetic Discharge Scoring System (PADSS), . Patients with a PADSS score ≥ 9 were discharged from the hospital by the escort of their relatives.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fast-Track Group | – | Other: Modified Aldrete Scoring System (mASS), Other: White's Fast-Track Scoring System (WFTSS), Other: SPEEDS criteriaAfter extubation, patients were evaluated using modified Aldrete Scoring System (mASS) , White's Fast- Track Scoring System (WFTSS) and SPEEDS criteria during 15 minutes with 3 min intervals. Patients who fulfilled criteria of all scoring systems were defined as eligible for PACU by-pass (fast-tracking) and transferred into phase II recovery area in the ward without observation in PACU (Group FT = Fast Track;) |
| PACU Group | – | Other: Modified Aldrete Scoring System (mASS), Other: White's Fast-Track Scoring System (WFTSS), Other: SPEEDS criteriaAfter extubation, patients were evaluated using modified Aldrete Scoring System (mASS) , White's Fast- Track Scoring System (WFTSS) and SPEEDS criteria during 15 minutes with 3 min intervals. Ineligible patients were taken into PACU where their treatments were continued until discharge criteria were achieved (Group PACU) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 122 ASA (American Society of Anesthesiologists) physical status I-II patients, aged between 18-65 years, undergoing elective lumbar discectomy under general anesthesia were included into the study.
Key inclusion criteria (3 listed)
- ASA (American Society of Anesthesiologists) physical status I-II patients
- elective primary lumbar discectomy performed for one or two vertebra levels under general anesthesia
- minimal risks for perioperative bleeding and airway safety
Key exclusion criteria (9 listed)
- patient's refusal
- urgent surgery,
- regional anesthesia,
- history of previous lumbar surgery
- difficult ventilation and intubation,
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 |
|---|---|---|
| Modified Aldrete Scoring System (mASS)Activity( Moves all extremities, Moves two extremities, Unable to move extremities), Respiration( Breathes deeply, coughs freely, Dyspneic, shallow or limited breathing, Apneic), Circulation (blood pressure) ( 20 mm Hg > preanesthetic level, 20 - 50 mm Hg > preanesthetic level, 50 mm Hg > preanesthetic level), Consciousness (Fully awake, Arousable on calling, Not responding), Oxygen saturation( SpO2 > 92% on room air, Supplemental O2 required to maintain SpO2 > 90%,SpO2 < 90% with O2 supplementation), scoring is done as 2,1,0, respectively. A score of 9 or more would be required for a patient after general anesthesia for discharge | Other | Fast-Track Group, PACU Group |
| White's Fast-Track Scoring System (WFTSS)Physical activity (Able to move all extremities on command, ,Some weakness in movement of extremities, Unable to voluntarily move extremities),Respiratory stability(Able to breathe deeply,Tachypnea,Dyspneic),Hemodynamic stability; (Blood pressure(MAP)<15%, Blood pressure 15-30%, Blood pressure>30%, Level of consciousness,(Awake\&orientated Arousable with minimal stimulation, Responsive only to tactile stimulation),Oxygen saturation status(Maintains value>90% on room air, Requires supplemental oxygen, Saturation<90% with supplemental oxygen), Postoperative pain assessment(None or mild discomfort, Moderate to severe pain controlled with analgesics, Persistent severe pain), Postoperative emetic symptoms(None or mild nausea w/no active vomiting, Transient vomiting or retching, Persistent moderate to severe nausea\&vomiting), Scoring is done as 2,1,0, respectively. A minimal score of 12(with no score<1 in any individual category)would be required for a patient after general anesthesia | Other | Fast-Track Group, PACU Group |
| SPEEDS criteriaExtremity movement (moves all four) Y/N, Stable vital signs( SBP > 90 and < 180, HR > 50 and < 110) Y/N, Dialogue (oriented person/place) Y/N, Oxygen saturation >90% in roExtremity movement (moves all four) Y/N, Stable vital signs( SBP > 90 and < 180, HR > 50 and < 110) Y/N, Dialogue (oriented person/place) Y/N, Oxygen saturation >90% in room air Y/N, Pain Control (VAS < 4) Y/N, Emesis Control Y/N. A patient must have a response of "yes" to all parameters to progress to phase II recovery | Other | Fast-Track Group, PACU Group |
Primary outcome
Duration of the surgery
Time frame: at the end of the surgery
the period (minutes) from the beginning of the surgery to the end of surgery
time to extubation
Time frame: 1 hour after extubation
the period (minutes) from the end of surgery until extubation
PACU( post-anesthesia care unit) by-pass rate
Time frame: 1 weeks after discharge from the hospital
The period (minutes) from admission to post-anesthesia care unit to discharge from the clinic
Time to hospital discharge
Time frame: 1 weeks after discharge from the hospital
The period (hours) from hospital admission to hospital discharge.
Time to PACU by-pass in group FT
Time frame: 1 weeks after discharge from the hospital
time(minutes) to be eligible for PACU by-pass in group FT according to scoring systems
time to PACU care in group PACU
Time frame: 1 weeks after discharge from the hospital
duration (minutes) of PACU care for patients in group PACU
patients who were eligible for fast-tracking
Time frame: through study completion, an average of 2 weeks
number patients who were eligible for fast-tracking
patients who were discharged from hospital
Time frame: through study completion, an average of 2 weeks
number patients who were discharged from hospital with respect to outpatient surgery (discharge time < 24 hours)
factors preventing
Time frame: through study completion, an average of 2 weeks
factors preventing fast-tracking and/or discharge from hospital in outpatient setting
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
Related trials for Lumbar Disc Disease
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Not yet recruitingObservational study
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
Intervertebral Disc Degeneration
Not yet recruiting
Cortical Surface Functional Changes After Lever Positioning Manipulation for Lumbar Disc Herniation
Lumbar Disc Herniation
Not yet recruiting
Effects of Spinal Mobilization With and Without Clinical Pilates in Patients With Lumbar Disc Herniationc Herniation
Disc Herniation
Enrolling by invitationObservational study
Intradiscal Ozone/Oxygen Injection for Treatment of Contained Lumbar Disc Herniation
Lumbar Disc Herniation
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.
Mehmet Ö ÖZHAN, M.D. study director
Çankaya Hospital, Department of Anesthesiology and Reanimation, Ankara, Turkey
Mehmet B. EŞKİN, M.D. principal investigator
Gulhane Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Disc Disease and Post-Op Complication, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
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 9 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 10 Mar 2020. 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 Turkey (Türkiye). 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.
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?
Duration of the surgery (time frame: at the end of the surgery). The study lists 9 primary outcomes in all. 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 10 Mar 2020.