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Completed

NCT Number: NCT04301232

Fast-Track Eligibility and Hospital Discharge for Outpatient Lumbar Discectomy

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

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Key information

Conditions

Lumbar Disc Disease Intervertebral disc disease Pathologic Processes Pathological Conditions, Signs and Symptoms Post-Op Complication Postoperative Complications

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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

Primary outcomes

  1. 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

  2. time to extubation

    Time frame: 1 hour after extubation

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

  3. 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

  4. Time to hospital discharge

    Time frame: 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

    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

  6. 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

  7. 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

  8. 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)

  9. factors preventing

    Time frame: through study completion, an average of 2 weeks

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

Sponsors and collaborators

Lead sponsor

Gulhane School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Mar 10, 2020
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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