Spinal Anesthesia Versus General Anesthesia Using Laryngeal Mask Airway for Anorectal Surgeries in Prone Position

Spinal Anesthesia Versus General Anesthesia Using Laryngeal Mask Airway for Anorectal Surgeries in Prone Position: A Controlled Clinical Trial

Anorectal surgeries are of the commonest elective surgeries that are performed worldwide under different types of anaesthesia. The aim of this prospective interventional study was to compare the use of general anaesthesia (GA) using a laryngeal mask airway (LMA) with spinal anesthesia (SA) in anorectal surgeries.

Study Overview

• Status: Completed
• Conditions: Anesthesia; Anorectal Surgery
• Intervention / Treatment: Procedure: Spinal Anesthesia for Anorectal Surgeries in Prone Position; Procedure: General Anesthesia Using Laryngeal Mask Airway for Anorectal Surgeries in Prone Position

Detailed Description

Anorectal surgeries are of the most frequently performed procedures worldwide. These procedures are commonly performed in prone position as it offers sufficient exposure and provides enough surgical space. Choosing the suitable anesthetic technique will help in reducing perioperative complications in patients undergoing surgical procedures in prone position, by taking into consideration changes in cardiovascular and pulmonary physiology, airway management, and proper positioning for the prevention of direct and indirect pressure injuries. The aim of this prospective interventional controlled study was to compare the use of general anesthesia (GA) using a laryngeal mask airway (LMA) with spinal anesthesia (SA) in anorectal surgeries.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Jordan
  • Amman, Jordan, 11942
    • Jordan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients undergoing elective anorectal surgery (perianal fistula surgery, haemorrhoidectomy, perianal abscess, pilonidal sinus, anal fissure or evaluation under anaesthesia).
• patients older than 16-years old.
• patients who have ASA score I-III.
• Patients whose BMI is less than 35 kg/m2.

Exclusion Criteria:

• any patient who refused to participate in the study.
• patients with surgeries for anal or rectal tumors.
• any patient with expected surgery's duration more than 90 minutes
• patients with uncontrolled respiratory conditions
• any patient whose preoperative assessment was suggestive of possibility of difficult airway.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group S; Patients in group S had spinal anesthesia in the sitting position under complete aseptic technique through a standard mid-line approach. The patient was then asked to turn him- or herself into the prone position on the surgical table with the help of the surgical and anesthetic teams.	Procedure: Spinal Anesthesia for Anorectal Surgeries in Prone Position; Spinal anesthesia in sitting position was done under complete aseptic technique through a standard midline approach. One and a half millilitres of 0.5% bupivacaine (7.5 mg) was injected through a 25 Gauge pencil-point needle into the subarachnoid space at L3-L4 or L4-L5 interspace. All patients were kept in a head-up position for 3 minutes. The patient was then asked to turn him- or herself into the prone position on the surgical table with the help of the surgical and anesthetic teams.
Experimental: group L; Patients in group L received standard general anesthesia. Proper (weight-based) classic laryngeal mask airway was then blindly inserted.	Procedure: General Anesthesia Using Laryngeal Mask Airway for Anorectal Surgeries in Prone Position; General anesthesia was induced using fentanyl 2 mcg/kg and Propofol 2-3 mg/kg. Any stomach contents were then suctioned through an oro-gastric tube to reduce the risk of regurgitation. Proper (weight-based) classic laryngeal mask airway was then blindly inserted. laryngeal mask airway was then properly fixed to the face and anesthesia was maintained with isoflurane 1-2% in 50% Oxygen/air mixture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparison was between the induction and emergence anesthesia times needed in each technique	In this group (L) the investigators defined induction time (T1) as the time from completion of initial monitoring until the patient is positioned prone. Emergence time (T2) was defined as the time from the end of surgical dressing till the removal of LMA in the supine position and the patient is ready for transfer to PACU. . In this group the investigators defined induction time (T1) as the time from the end of initial monitoring till the patient is positioned in prone position, and (T2) as the time from the end of surgical dressing till the patient is turned to supine position on the bed and ready to be transferred to PACU.	4 months

Collaborators and Investigators

• Sponsor: University of Jordan

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2019
• Primary Completion (Actual): August 14, 2019
• Study Completion (Actual): August 15, 2019

Study Registration Dates

• First Submitted: December 28, 2019
• First Submitted That Met QC Criteria: December 28, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Actual): January 3, 2020
• Last Update Submitted That Met QC Criteria: December 31, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: general anaesthesia; spinal anaesthesia; laryngeal mask; Anorectal surgeries; prone
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 67/2019/1174

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No