Skip to content

Fast-Track Eligibility and Hospital Discharge for Outpatient Lumbar Discectomy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04301232
Enrollment
122
Registered
2020-03-10
Start date
2018-05-10
Completion date
2020-01-28
Last updated
2020-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Disc Disease, Post-Op Complication

Keywords

PACU-bypass, hospital discharge, lumbar discectomy

Brief 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. 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.

Interventions

OTHERModified 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

OTHERWhite'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

OTHERSPEEDS criteria

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

Sponsors

Gulhane School of Medicine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Duration of the surgeryat the end of the surgerythe period (minutes) from the beginning of the surgery to the end of surgery
time to extubation1 hour after extubationthe period (minutes) from the end of surgery until extubation
PACU( post-anesthesia care unit) by-pass rate1 weeks after discharge from the hospitalThe period (minutes) from admission to post-anesthesia care unit to discharge from the clinic
Time to hospital discharge1 weeks after discharge from the hospitalThe period (hours) from hospital admission to hospital discharge.
Time to PACU by-pass in group FT1 weeks after discharge from the hospitaltime(minutes) to be eligible for PACU by-pass in group FT according to scoring systems
time to PACU care in group PACU1 weeks after discharge from the hospitalduration (minutes) of PACU care for patients in group PACU
patients who were eligible for fast-trackingthrough study completion, an average of 2 weeksnumber patients who were eligible for fast-tracking
patients who were discharged from hospitalthrough study completion, an average of 2 weeksnumber patients who were discharged from hospital with respect to outpatient surgery (discharge time \< 24 hours)
factors preventingthrough study completion, an average of 2 weeksfactors preventing fast-tracking and/or discharge from hospital in outpatient setting

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026