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

NCT04214977 | Completed

• 1 other identifier: 67/2019/1174
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia; Anorectal Surgery

Keywords

Anorectal surgeries; prone; spinal anaesthesia; general anaesthesia; laryngeal mask

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

group S

EXPERIMENTAL

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

group L

EXPERIMENTAL

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

Interventions

Spinal Anesthesia for Anorectal Surgeries in Prone Position PROCEDURE

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.

group S

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

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.

group L

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

Jordan University Hospital

Amman, 11942, Jordan

Location

MeSH Terms

Interventions

Anesthesia, Spinal; Prone Position

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 28, 2019
• First Posted: January 2, 2020
• Study Start: April 25, 2019
• Primary Completion: August 14, 2019
• Study Completion: August 15, 2019
• Last Updated: January 3, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)