AnesthesiaNCT04214977
Spinal Anesthesia Versus General Anesthesia Using Laryngeal Mask Airway for Anorectal Surgeries in Prone Position
A study testing Spinal Anesthesia for Anorectal Surgeries in Prone Position and General Anesthesia Using Laryngeal Mask Airway for Anorectal Surgeries in Prone Position in people with Anesthesia and Anorectal Surgery, run by University of Jordan at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Anorectal Surgery
- What is being tested?
- Spinal Anesthesia for Anorectal Surgeries in Prone Position and General Anesthesia Using Laryngeal Mask Airway for Anorectal Surgeries in Prone Position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteJordan
- Study dates
- 25 Apr 2019to 15 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anesthesia, Anorectal Surgery
- Being tested
- Spinal Anesthesia for Anorectal Surgeries in Prone Position, General Anesthesia Using Laryngeal Mask Airway for Anorectal Surgeries in Prone Position
- Keywords
- Anorectal surgeries, prone, spinal anaesthesia, general anaesthesia, laryngeal mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Anesthesia for Anorectal Surgeries in Prone PositionProcedure or surgery
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 PositionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: General Anesthesia Using Laryngeal Mask Airway for Anorectal Surgeries in Prone Position |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start25 Apr 2019
- Primary completion14 Aug 2019
- Study completion15 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud M. Almustafa, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04214977
- Sponsor's protocol ID
- 67/2019/1174
- Status last verified
- Dec 2019
- First submitted
- 28 Dec 2019
- Last updated
- 3 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Anesthesia Versus General Anesthesia Using Laryngeal Mask Airway for Anorectal Surgeries in Prone Position: A Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04214977
- Acronym / sponsor ID
- 67/2019/1174
- Conditions
- Anesthesia, Anorectal Surgery
- Keywords
- Anorectal surgeries, prone, spinal anaesthesia, general anaesthesia, laryngeal mask
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 25 Apr 2019 (actual)
- Primary completion
- 14 Aug 2019 (actual)
- Study completion
- 15 Aug 2019 (actual)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group S | Experimental | Procedure: Spinal Anesthesia for Anorectal Surgeries in Prone PositionPatients 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. |
| group L | Experimental | Procedure: General Anesthesia Using Laryngeal Mask Airway for Anorectal Surgeries in Prone PositionPatients in group L received standard general anesthesia. Proper (weight-based) classic laryngeal mask airway was then blindly inserted. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal Anesthesia for Anorectal Surgeries in Prone PositionSpinal 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. | Procedure or surgery | group S |
| General Anesthesia Using Laryngeal Mask Airway for Anorectal Surgeries in Prone PositionGeneral 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. | Procedure or surgery | group L |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Anesthesia for Anorectal Surgeries in Prone Position and General Anesthesia Using Laryngeal Mask Airway for Anorectal Surgeries in Prone Position in people with Anesthesia and Anorectal Surgery, run by University of Jordan at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison was between the induction and emergence anesthesia times needed in each technique (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2020.