Fast-Track Eligibility and Hospital Discharge for Outpatient Lumbar Discectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Fast-Track Eligibility and Hospital Discharge for Outpatient Lumbar Discectomy: A Prospective Observational Study

Conditions
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Lumbar Disc Disease, Post-Op Complication

Intervention / Treatment
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* Other: Modified Aldrete Scoring System (mASS)
* Other: White's Fast-Track Scoring System (WFTSS)
* Other: SPEEDS criteria


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: patient's refusal urgent surgery, regional anesthesia, history of previous lumbar surgery difficult ventilation and intubation, treatment for chronic pain obstructive sleep apnea, morbid obesity (BMI≥40 kg/m2) allergy to drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fast-Track Group<br>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;) | Other: Modified Aldrete Scoring System (mASS)<br>* 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<br>Other: White's Fast-Track Scoring System (WFTSS)<br>* 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<br>Other: SPEEDS criteria<br>* 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<br>|
| PACU Group<br>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) | Other: Modified Aldrete Scoring System (mASS)<br>* 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<br>Other: White's Fast-Track Scoring System (WFTSS)<br>* 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<br>Other: SPEEDS criteria<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of the surgery | the period (minutes) from the beginning of the surgery to the end of surgery | at the end of the surgery | 
| time to extubation | the period (minutes) from the end of surgery until extubation | 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 | 1 weeks after discharge from the hospital | 
| Time to hospital discharge | The period (hours) from hospital admission to hospital discharge. | 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 | 1 weeks after discharge from the hospital | 
| time to PACU care in group PACU | duration (minutes) of PACU care for patients in group PACU | 1 weeks after discharge from the hospital | 
| patients who were eligible for fast-tracking | number patients who were eligible for fast-tracking | 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) | through study completion, an average of 2 weeks | 
| factors preventing | factors preventing fast-tracking and/or discharge from hospital in outpatient setting | through study completion, an average of 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PACU-bypass, hospital discharge, lumbar discectomy