Fast-Track Eligibility and Hospital Discharge for Outpatient Lumbar Discectomy

NCT04301232 | Completed

• 1 other identifier: 18/148
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

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

Conditions

Lumbar Disc Disease; Post-Op Complication

Keywords

PACU-bypass; hospital discharge; lumbar discectomy

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

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); 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)

Other: Modified Aldrete Scoring System (mASS); Other: White's Fast-Track Scoring System (WFTSS); Other: SPEEDS criteria

Interventions

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

Fast-Track Group; PACU Group

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

Fast-Track Group; PACU Group

SPEEDS criteria OTHER

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

Fast-Track Group; PACU Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gulhane School of Medicine: lead

Study Sites (1)

Çankaya Hospital, Department of Anesthesiology and Reanimation, Ankara, Turkey

Ankara, Çankaya/ANKARA, 06010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intervertebral disc disease; Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mehmet Ö ÖZHAN, M.D.

  Çankaya Hospital, Department of Anesthesiology and Reanimation, Ankara, Turkey

  STUDY DIRECTOR

• Mehmet B. EŞKİN, M.D.

  Gulhane Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 10, 2020
• Study Start: May 10, 2018
• Primary Completion: December 12, 2019
• Study Completion: January 28, 2020
• Last Updated: March 10, 2020

Record last verified: 2020-03

Locations

TU (1)