Postoperative ComplicationsNCT05291221
Intratracheal Dexmedetomidine Versus Lidocaine in Eye Surgery
A study testing intratracheal saline, intratracheal Dexmedetomidine and intratracheal Lidocaine in people with Postoperative Complications, run by Minia University at 1 site in Egypt.
Trial summary
Cough during emergence from general anesthesia is considered a critical event as it may lead to surgical bleeding laryngospasm hemodynamic instability and could be life-threatening in patients who are at risk of complications related to increases in intracranial or intraocular pressure. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- intratracheal saline, intratracheal Dexmedetomidine and intratracheal Lidocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Feb 2021to 30 Jul 2022
- 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 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adult patients aged from 18 to 60 years old
- ASA I or II class
- Undergo elective intraocular surgery
- Under general anesthesia.
Who cannot join
- Renal impairment
- Cardiorespiratory abnormalities
- Bronchial asthma COPD
- Restrictive lung diseases
- Liver failure
- Allergy to drugs will be used
Show all 9Show fewer
- Patient refuse
- Pregnancy-lactation
- Significant obesity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Safety of Intratracheal Dexmedetomidine Versus Lidocaine for Smooth Tracheal Extubation in Patients Undergoing Eye-surgery.
Cough during emergence from general anesthesia is considered a critical event as it may lead to surgical bleeding laryngospasm hemodynamic instability and could be life-threatening in patients who are at risk of complications related to increases in intracranial or intraocular pressure. Lidocaine administration has been widely used for reducing cough during extubation due to its simplicity and lack of serious adverse effects; There are two major routes for lidocaine administration systemic intravenous injection and local direct application on the laryngeal inlets such as spraying lidocaine on the supraglottic and subglottic regions or applying lidocaine jelly or sprayed. Dexmedetomidine is a potent alpha 2 selective adrenoceptor agonist and the most characteristic features include sympatholytic sedation analgesia and lack of respiratory depression. The aim of this study is to compare the effect of intratracheal dexmedetomidine and lidocaine on cough reflex in cataract surgery.
Read the detailed description
The patients were randomly allocated into three groups each containing (40) patient. Group D received (0.5 μg/kg) of dexmedetomidine diluted and completed to 5 ml saline, Group L received (5ml) 2% of lidocaine and Group C received 5ml saline. The drugs were sprayed down the intratracheal tube of patients.
The following variables: Hemodynamic parameters HR, MAP, and SaO2 values in different times, preoperative IOP, cough, steward recovery score (SRS), detection of awareness and extubation time, the incidence of complications due to increasing IOP and surgeon satisfaction
- Conditions
- Postoperative Complications
- Being tested
- intratracheal saline, intratracheal Dexmedetomidine, intratracheal Lidocaine
- Keywords
- intratracheal, dexmedetomidine, eye-surgery, lidocaine
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intratracheal salineDrug
Also called Group C
At the end of the operation by 15min, 5ml of 0.9% normal saline was sprayed down the intratracheal tube of patients
intratracheal DexmedetomidineDrug
Also called Group D
At the end of the operation by 15min, Dexmedetomidine (0.5µg/kg, diluted in 5mL saline in a medical spray bottle) was sprayed down the intratracheal tube of patients
intratracheal LidocaineDrug
Also called Group L
At the end of the operation by 15min, (5ml) 2% of lidocaine was sprayed down the intratracheal tube of patients.
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | At the end of the operation by 15min, 5ml saline in a medical spray bottle was sprayed down the intratracheal tube of patients. Receives: Drug: intratracheal saline |
| Dexmedetomidine | Active comparator | At the end of the operation by 15min, Dexmedetomidine (0.5µg/kg, diluted in 5mL saline in a medical spray bottle) was sprayed down the intratracheal tube of patients Receives: Drug: intratracheal Dexmedetomidine |
| Lidocaine | Active comparator | At the end of the operation by 15min, (5ml) 2% of lidocaine was sprayed down the intratracheal tube of patients. Receives: Drug: intratracheal Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough reflex.
To evaluate efficacy and safety of both dexmedetomidine and lidocaine on Cough: from time of awareness to 5 minute after extubation 0= no cough
- minimal Cough (single)
- moderate cough<= 5S
- severe cough >=5S (bucking)
Measured: from time of awareness to 5 minute after extubation
Secondary outcomes (2)
mean arterial blood pressure
Perioperative mean arterial blood pressure values were recorded
Measured: before anesthesia up to 30 minute after extubation
heart rate
Perioperative heart rate values were recorded
Measured: before anesthesia up to 30 minute after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start22 Feb 2021
- Primary completion1 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Minia 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, haidy salah mansour, Minia University
- Investigators
- Sohair A Magala, Lecturer, Study director, Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291221
- Sponsor's protocol ID
- 22-2021
- Status last verified
- Jul 2023
- First submitted
- 19 Feb 2022
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Intratracheal Dexmedetomidine Versus Lidocaine for Smooth Tracheal Extubation in Patients Undergoing Eye-surgery.
- ClinicalTrials.gov ID
- NCT05291221
- Acronym / sponsor ID
- 22-2021
- Conditions
- Postoperative Complications
- Keywords
- intratracheal, dexmedetomidine, eye-surgery, lidocaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 22 Mar 2022 (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.
Cough during emergence from general anesthesia is considered a critical event as it may lead to surgical bleeding laryngospasm hemodynamic instability and could be life-threatening in patients who are at risk of complications related to increases in intracranial or intraocular pressure. Lidocaine administration has been widely used for reducing cough during extubation due to its simplicity and lack of serious adverse effects; There are two major routes for lidocaine administration systemic intravenous injection and local direct application on the laryngeal inlets such as spraying lidocaine on the supraglottic and subglottic regions or applying lidocaine jelly or sprayed. Dexmedetomidine is a potent alpha 2 selective adrenoceptor agonist and the most characteristic features include sympatholytic sedation analgesia and lack of respiratory depression. The aim of this study is to compare the effect of intratracheal dexmedetomidine and lidocaine on cough reflex in cataract surgery.
Detailed description
The patients were randomly allocated into three groups each containing (40) patient. Group D received (0.5 μg/kg) of dexmedetomidine diluted and completed to 5 ml saline, Group L received (5ml) 2% of lidocaine and Group C received 5ml saline. The drugs were sprayed down the intratracheal tube of patients.
The following variables: Hemodynamic parameters HR, MAP, and SaO2 values in different times, preoperative IOP, cough, steward recovery score (SRS), detection of awareness and extubation time, the incidence of complications due to increasing IOP and surgeon satisfaction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | Placebo comparator | Drug: intratracheal salineAt the end of the operation by 15min, 5ml saline in a medical spray bottle was sprayed down the intratracheal tube of patients. |
| Dexmedetomidine | Active comparator | Drug: intratracheal DexmedetomidineAt the end of the operation by 15min, Dexmedetomidine (0.5µg/kg, diluted in 5mL saline in a medical spray bottle) was sprayed down the intratracheal tube of patients |
| Lidocaine | Active comparator | Drug: intratracheal LidocaineAt the end of the operation by 15min, (5ml) 2% of lidocaine was sprayed down the intratracheal tube of patients. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Adult patients aged from 18 to 60 years old
- ASA I or II class
- Undergo elective intraocular surgery
- Under general anesthesia.
Key exclusion criteria (9 listed)
- Renal impairment
- Cardiorespiratory abnormalities
- Bronchial asthma COPD
- Restrictive lung diseases
- Liver failure
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 |
|---|---|---|
| intratracheal salineAlso: Group CAt the end of the operation by 15min, 5ml of 0.9% normal saline was sprayed down the intratracheal tube of patients | Drug | control |
| intratracheal DexmedetomidineAlso: Group DAt the end of the operation by 15min, Dexmedetomidine (0.5µg/kg, diluted in 5mL saline in a medical spray bottle) was sprayed down the intratracheal tube of patients | Drug | Dexmedetomidine |
| intratracheal LidocaineAlso: Group LAt the end of the operation by 15min, (5ml) 2% of lidocaine was sprayed down the intratracheal tube of patients. | Drug | Lidocaine |
Primary outcome
Cough reflex.
Time frame: from time of awareness to 5 minute after extubation
To evaluate efficacy and safety of both dexmedetomidine and lidocaine on Cough: from time of awareness to 5 minute after extubation 0= no cough 1. minimal Cough (single) 2. moderate cough<= 5S 3. severe cough >=5S (bucking)
2 secondary outcomes
mean arterial blood pressure
Time frame: before anesthesia up to 30 minute after extubation
heart rate
Time frame: before anesthesia up to 30 minute after extubation
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 1 Aug 2023.
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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.
Sohair A Magala, Lecturer study director
Lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intratracheal saline, intratracheal Dexmedetomidine and intratracheal Lidocaine in people with Postoperative Complications, run by Minia 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 4 inclusion and 9 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 1 Aug 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. Some participants in this study may receive a placebo. 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?
Cough reflex. (time frame: from time of awareness to 5 minute after extubation). 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 1 Aug 2023.