Fast-Track Eligibility and Hospital Discharge for Outpatient Lumbar Discectomy

Sponsor
Gulhane School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT04301232
Collaborator
(none)
122
1
20.6
5.9

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Modified Aldrete Scoring System (mASS)
  • Other: White's Fast-Track Scoring System (WFTSS)
  • Other: 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

Study Type:
Observational [Patient Registry]
Actual Enrollment :
122 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Fast-Track Eligibility and Hospital Discharge for Outpatient Lumbar Discectomy: A Prospective Observational Study
Actual Study Start Date :
May 10, 2018
Actual Primary Completion Date :
Dec 12, 2019
Actual Study Completion Date :
Jan 28, 2020

Arms and Interventions

Arm Intervention/Treatment
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;)

Other: 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: 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: SPEEDS 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

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)

Other: 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: 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: SPEEDS 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

Outcome Measures

Primary Outcome Measures

  1. Duration of the surgery [at the end of the surgery]

    the period (minutes) from the beginning of the surgery to the end of surgery

  2. time to extubation [1 hour after extubation]

    the period (minutes) from the end of surgery until extubation

  3. PACU( post-anesthesia care unit) by-pass rate [1 weeks after discharge from the hospital]

    The period (minutes) from admission to post-anesthesia care unit to discharge from the clinic

  4. Time to hospital discharge [1 weeks after discharge from the hospital]

    The period (hours) from hospital admission to hospital discharge.

  5. Time to PACU by-pass in group FT [1 weeks after discharge from the hospital]

    time(minutes) to be eligible for PACU by-pass in group FT according to scoring systems

  6. time to PACU care in group PACU [1 weeks after discharge from the hospital]

    duration (minutes) of PACU care for patients in group PACU

  7. patients who were eligible for fast-tracking [through study completion, an average of 2 weeks]

    number patients who were eligible for fast-tracking

  8. patients who were discharged from hospital [through study completion, an average of 2 weeks]

    number patients who were discharged from hospital with respect to outpatient surgery (discharge time < 24 hours)

  9. factors preventing [through study completion, an average of 2 weeks]

    factors preventing fast-tracking and/or discharge from hospital in outpatient setting

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Çankaya Hospital, Department of Anesthesiology and Reanimation, Ankara, Turkey Ankara Çankaya/ANKARA Turkey 06010

Sponsors and Collaborators

  • Gulhane School of Medicine

Investigators

  • Study Director: Mehmet Ö ÖZHAN, M.D., Çankaya Hospital, Department of Anesthesiology and Reanimation, Ankara, Turkey
  • Principal Investigator: Mehmet B. EŞKİN, M.D., Gulhane Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mehmet Burak Eşkin, Assistant professor, Gulhane School of Medicine
ClinicalTrials.gov Identifier:
NCT04301232
Other Study ID Numbers:
  • 18/148
First Posted:
Mar 10, 2020
Last Update Posted:
Mar 10, 2020
Last Verified:
Mar 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mehmet Burak Eşkin, Assistant professor, Gulhane School of Medicine
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2020