Effects of; Anesthesia, Local,Pain,in DISENCT04300595
Anesthetic Approaches for Dacryocystorhinostomy Surgery: The Effect of Adding Local Anesthesia to General Inhalational Anesthesia
A study testing Combination of General anesthesia and local anesthesia in dacryocystorhinostomy surgery in people with Effects of; Anesthesia, Local,Pain,in DISE, run by Zagazig University at 1 site in Egypt.
Trial summary
To Study the effect of combination of of general anesthesia and local anesthesia in anesthesia for external dacryocystorhinostomy and assess quality of the procedure Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Effects of; Anesthesia, Local,Pain,in DISE
- What is being tested?
- Combination of General anesthesia and local anesthesia in dacryocystorhinostomy surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2020to 30 Jul 2023
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American society of anesthesiologists (ASA) physical status I or II.
- Elective unilateral Dacryocystorhinostomy with paranasal skin incision.
Who cannot join
- Endoscopic Dacryocystorhinostomy.
- Allergy to amide local anesthetics or opioids.
- Drug abuse.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Zagazig University
Zagazig, Sharqia Province, 002055
Zagazig University, 0552363635, info_medicine@zu.edu.eg
About this study
Official title: The Efficacy of Combined Local and General Anesthesia or General Anesthesia Alone in External Dacryocystorhinostomy: A Randomized Controlled Study
To Study the effect of combination of of general anesthesia and local anesthesia in anesthesia for external dacryocystorhinostomy and assess quality of the procedure
Read the detailed description
- calculate the total requirement for anaesthetic agents to maintain satisfactory operating conditions
- calculate total anesthetic time
- assess intraoperative changes in hemodynamics
- assess intraoperative blood loss
- evaluate surgeon and patient satisfaction
- recognize whether this was related with changes in postoperative analgesia .
- Also occurrence of postoperative nausea was recorded and compared with general anaesthesia combined with intravenous opioid for (EXT-DCR) surgery.
- Being tested
- Combination of General anesthesia and local anesthesia in dacryocystorhinostomy surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of General anesthesia and local anesthesia in dacryocystorhinostomy surgeryProcedure or surgery
all patients were assigned randomly to receive either general anesthesia with intravenous opioids and local infiltration of saline (Group G) or general anesthesia with intravenous saline and local infiltration of a mixture of lidocaine/epinephrine (Group L).
In both groups, general anesthesia was induced with 2 mg/kg propofol and tracheal intubation was facilitated by 0.1 mg/kg cisatracurium. All patients underwent mechanical ventilation with 100% oxygen. Anesthesia was maintained with isoflurane, and muscle relaxation was provided by an injection of cisatracurium 0.02 mg/kg every 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| general anesthesia (Group G) | Active comparator | Patients receive general anesthesia with intravenous opioids and local infiltration of saline (Group G) Receives: Procedure: Combination of General anesthesia and local anesthesia in dacryocystorhinostomy surgery |
| Local anesthesia (Group L) | Active comparator | Patients receive general anesthesia with intravenous saline and local infiltration of a mixture of lidocaine/epinephrine (Group L). Receives: Procedure: Combination of General anesthesia and local anesthesia in dacryocystorhinostomy surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain assessment
To quantify the intensity of postoperative pain, the patients were asked to use a 10-cm visual analog scale (VAS) grade from 0-cm (no pain) to 10-cm (the worst possible pain) 1, 2, 4, 6, 8, 12, and 24 h after extubation
Measured: change in visual analogue scale at 1, 2, 4, 6, 8, 12, and 24 hours postoperative after extubation
hemodynamic assessment
Change in heart rate were recorded preoperatively, after induction of general anesthesia, after IV injection of 10 ml syringe and after local infiltration, then every 5 min intraoperatively, and during early recovery, and every 30 min, thereafter for 24 hours
Measured: for 24 hours
hemodynamic assessment
Change in arterial blood pressure were recorded preoperatively, after induction of general anesthesia, after IV injection of 10 ml syringe and after local infiltration, then every 5 min intraoperatively, and during early recovery, and every 30 min, thereafter for 24 hours
Measured: for 24 hours
Secondary outcomes (6)
extubation time
Extubation time was calculated from time of anesthesia off till extubation and recorded in each patient
Measured: intraoperative (from time of anesthesia ended till extubation and recorded in each patient in minutes)
mean isoflurane %
Isoflurane concentration was adjusted according to hemodynamics by increase or decrease concentration when heart rate or mean arterial blood pressure increase or decrease more than 20-30% of the basal preoperative record, respectively and after nalbuphine dose failed to adjust hemodynamics
Measured: intraoperative ( recorded every 5 minutes)
time to rescue analgesia
The time from the end of anaesthesia to first use of rescue analgesia (nalbuphine)
Measured: up to 24 hours of postoperative
The number of patients who required nalbuphine in the postoperative period,
to calculate the number of patients who required nalbuphine in the postoperative period,
Measured: up to 24 hours of postoperative
intraoperative bleeding
to the nearest milliliter) was determined by the amount of blood in the suction containers and gauze sponges, based on assessment by the surgeon.
Measured: at the end of surgery
patient and surgeon satisfaction
An overall satisfaction score according to postoperative analgesia .
- nil = 0
- mild = 1
- good = 2
- excellent = 3 was recorded on the first postoperative day from both patients and surgeons. The acceptance of combination of LA and GA was questioned and the patients who applied for a successive operation on the other eye were recorded
Measured: assessed on the first postoperative day from both patients and surgeons.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start1 Apr 2020
- Primary completion30 Jul 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Effects of; Anesthesia, Local,Pain,in DISEStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The day before surgery and after obtaining written informed consent and full history taking, all patients were assigned randomly to receive either general anesthesia with intravenous opioids and local infiltration of saline (Group G) or general anesthesia with intravenous saline and local infiltration of a mixture of lidocaine/epinephrine (Group L).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Heba Mohamed EL -Asser,MD, Zagazig University
- Investigators
- Heba M EL-Asser, MD, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300595
- Sponsor's protocol ID
- local anesthesia in DCR
- Status last verified
- Jul 2023
- First submitted
- 17 Feb 2020
- Last updated
- 18 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Scawn RL, Allen MJ, Rose GE, Verity DH. Randomised, masked study of local anaesthesia administered prior to external dacryocystorhinostomy under general anaesthesia. Eye (Lond). 2019 Mar;33(3):374-379. doi: 10.1038/s41433-018-0201-5. Epub 2018 Sep 18.
PubMed 30228368Ghali AM, El Btarny AM. The effect on outcome of peribulbar anaesthesia in conjunction with general anesthesia for vitreoretinal surgery. Anaesthesia. 2010 Mar;65(3):249-53. doi: 10.1111/j.1365-2044.2009.06191.x. Epub 2009 Dec 23.
PubMed 20039868
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Combined Local and General Anesthesia or General Anesthesia Alone in External Dacryocystorhinostomy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04300595
- Acronym / sponsor ID
- local anesthesia in DCR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 9 Mar 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.
To Study the effect of combination of of general anesthesia and local anesthesia in anesthesia for external dacryocystorhinostomy and assess quality of the procedure
Detailed description
- calculate the total requirement for anaesthetic agents to maintain satisfactory operating conditions
- calculate total anesthetic time
- assess intraoperative changes in hemodynamics
- assess intraoperative blood loss
- evaluate surgeon and patient satisfaction
- recognize whether this was related with changes in postoperative analgesia .
- Also occurrence of postoperative nausea was recorded and compared with general anaesthesia combined with intravenous opioid for (EXT-DCR) surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The day before surgery and after obtaining written informed consent and full history taking, all patients were assigned randomly to receive either general anesthesia with intravenous opioids and local infiltration of saline (Group G) or general anesthesia with intravenous saline and local infiltration of a mixture of lidocaine/epinephrine (Group L).
| Arm | Type | Receives |
|---|---|---|
| general anesthesia (Group G) | Active comparator | Procedure: Combination of General anesthesia and local anesthesia in dacryocystorhinostomy surgeryPatients receive general anesthesia with intravenous opioids and local infiltration of saline (Group G) |
| Local anesthesia (Group L) | Active comparator | Procedure: Combination of General anesthesia and local anesthesia in dacryocystorhinostomy surgeryPatients receive general anesthesia with intravenous saline and local infiltration of a mixture of lidocaine/epinephrine (Group L). |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American society of anesthesiologists (ASA) physical status I or II.
- Elective unilateral Dacryocystorhinostomy with paranasal skin incision.
Key exclusion criteria (4 listed)
- Endoscopic Dacryocystorhinostomy.
- Allergy to amide local anesthetics or opioids.
- Drug abuse.
- Pregnancy.
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 |
|---|---|---|
| Combination of General anesthesia and local anesthesia in dacryocystorhinostomy surgeryall patients were assigned randomly to receive either general anesthesia with intravenous opioids and local infiltration of saline (Group G) or general anesthesia with intravenous saline and local infiltration of a mixture of lidocaine/epinephrine (Group L). In both groups, general anesthesia was induced with 2 mg/kg propofol and tracheal intubation was facilitated by 0.1 mg/kg cisatracurium. All patients underwent mechanical ventilation with 100% oxygen. Anesthesia was maintained with isoflurane, and muscle relaxation was provided by an injection of cisatracurium 0.02 mg/kg every 20 minutes. | Procedure or surgery | Local anesthesia (Group L), general anesthesia (Group G) |
Primary outcome
postoperative pain assessment
Time frame: change in visual analogue scale at 1, 2, 4, 6, 8, 12, and 24 hours postoperative after extubation
To quantify the intensity of postoperative pain, the patients were asked to use a 10-cm visual analog scale (VAS) grade from 0-cm (no pain) to 10-cm (the worst possible pain) 1, 2, 4, 6, 8, 12, and 24 h after extubation
hemodynamic assessment
Time frame: for 24 hours
Change in heart rate were recorded preoperatively, after induction of general anesthesia, after IV injection of 10 ml syringe and after local infiltration, then every 5 min intraoperatively, and during early recovery, and every 30 min, thereafter for 24 hours
hemodynamic assessment
Time frame: for 24 hours
Change in arterial blood pressure were recorded preoperatively, after induction of general anesthesia, after IV injection of 10 ml syringe and after local infiltration, then every 5 min intraoperatively, and during early recovery, and every 30 min, thereafter for 24 hours
6 secondary outcomes
extubation time
Time frame: intraoperative (from time of anesthesia ended till extubation and recorded in each patient in minutes)
mean isoflurane %
Time frame: intraoperative ( recorded every 5 minutes)
time to rescue analgesia
Time frame: up to 24 hours of postoperative
The number of patients who required nalbuphine in the postoperative period,
Time frame: up to 24 hours of postoperative
intraoperative bleeding
Time frame: at the end of surgery
patient and surgeon satisfaction
Time frame: assessed on the first postoperative day from both patients and surgeons.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Background: PubMed 30228368Scawn RL, Allen MJ, Rose GE, Verity DH. Randomised, masked study of local anaesthesia administered prior to external dacryocystorhinostomy under general anaesthesia. Eye (Lond). 2019 Mar;33(3):374-379. doi: 10.1038/s41433-018-0201-5. Epub 2018 Sep 18.
- Background: PubMed 20039868Ghali AM, El Btarny AM. The effect on outcome of peribulbar anaesthesia in conjunction with general anesthesia for vitreoretinal surgery. Anaesthesia. 2010 Mar;65(3):249-53. doi: 10.1111/j.1365-2044.2009.06191.x. Epub 2009 Dec 23.
- Individual participant dataSharing planned: No
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.
Heba M EL-Asser, MD principal investigator
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combination of General anesthesia and local anesthesia in dacryocystorhinostomy surgery in people with Effects of; Anesthesia, Local,Pain,in DISE, run by Zagazig University at 1 site in Egypt.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 Jul 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heba M EL-Asser, MD (00201062393152, aseeaswad1@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain assessment (time frame: change in visual analogue scale at 1, 2, 4, 6, 8, 12, and 24 hours postoperative after extubation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04300595, which also lists 2 linked publications.
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 18 Jul 2023.