Skip to main content
OpenTrials
Completed

NCT Number: NCT04214977

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anesthesia Anorectal Surgery

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jordan University Hospital

Amman, 11942, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. comparison was between the induction and emergence anesthesia times needed in each technique

    Time frame: 4 months

    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.

Sponsors and collaborators

Lead sponsor

University of Jordan

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 2, 2020
Registry last updated
Jan 3, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.