Fast-Track Eligibility and Hospital Discharge for Outpatient Lumbar Discectomy

Post-Op Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04301232
• Other study ID #: 18/148
• Status: Completed
• Start date: May 10, 2018
• Est. completion date: January 28, 2020

Study information

• Verified date: March 2020
• Source: Gulhane School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: January 28, 2020
• Est. primary completion date: December 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lumbar Disc Disease
• Post-Op Complication
• Postoperative Complications

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
Turkey	Çankaya Hospital, Department of Anesthesiology and Reanimation, Ankara, Turkey	Ankara	Çankaya/ANKARA

Sponsors (1)

Lead Sponsor	Collaborator
Gulhane School of Medicine

Country where clinical trial is conducted

Turkey, 

Outcome

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