Pressor ResponsePhase 4NCT04441073
Lignocaine Nebulization for Attenuation of Intubation Stress Response
A Phase 4 study testing Lignocaine in people with Pressor Response, run by Assiut University at 1 site in Egypt.
Trial summary
To study the effect of lignocaine nebulization on attenuation of the pressor response during induction and emergence of anesthesia in patients with severe pre-eclampsia Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pressor Response
- What is being tested?
- Lignocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Feb 2021to 23 Feb 2022
- Phase
- Phase 4
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologist (ASA) II , III with severe pre-eclampsia
- Scheduled for caesarean deliveries under general anesthesia
Who cannot join
- severe obesity (BMI ≥ 40 )
- Cardiac patients
- History of diabetes
- Renal dysfunction (Elevated creatinine ≥ 2 mg\dl)
- Hepatic dysfunction (Elevated hepatic enzymes three times above normal value)
- Known fetal anomalies
Trial locations and contacts
1 site in 1 country.
Alaa A. Gharib, M.B.B.Ch. contact
Egypt1 site, 1 recruiting
- Recruiting
Assiut University
Asyut, 71515
Fatma N. Mohamed, M.D., +201003633992, fatmanabil2012@gmail.com
Alaa Gharib, lola.gh2022@gmail.com
About this study
Official title: Lignocaine Nebulization for Attenuation of Intubation Stress Response in Patients With Severe Pre-eclampsia: a Prospective Double-blinded Placebo-controlled Trial
To study the effect of lignocaine nebulization on attenuation of the pressor response during induction and emergence of anesthesia in patients with severe pre-eclampsia
Read the detailed description
The pressor response to laryngoscopy and tracheal intubation is a very important issue in hypertensive pregnant patients that can lead to increased maternal intracranial pressure, cerebral haemorrhage, and cardiac failure with pulmonary oedema and may result in maternal mortality. The catecholamine release associated with laryngoscopy and intubation also causes uteroplacental vasoconstriction and adversely affect the neonate well-being.
Therefore, the precise control of stress is necessary during general anesthesia in pre-eclamptic patients.Various drugs are used to suppress the pressor response including opioids, lidocaine, along with α and β adrenergic blockers.
in this study the investigators will evaluate the effect of lignocaine nebulization on attenuation of the pressor response.
- Conditions
- Pressor Response
- Being tested
- Lignocaine, Placebo
- Keywords
- pressor response, pre-eclampsia, Lignocaine
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LignocaineDrug
preoperative nebulization of lignocaine
PlaceboDrug
Also called Normal saline (Nacl 0.9%)
preoperative nebulization of normal saline (Nacl 0.9%) as a placebo
| Study group | Role | What they receive |
|---|---|---|
| Lignocaine | Experimental | preoperative nebulization of lignocaine Receives: Drug: Lignocaine |
| Placebo | Placebo comparator | preoperative nebulization of normal saline (Nacl 0.9%) as a placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic, diastolic, mean arterial blood pressure
Measured: Preoperative-Intraoperative
Heart rate
Measured: Preoperative-Intraoperative
Peripheral oxygen saturation
Measured: Preoperative-Intraoperative
Cough score during emergence
Grade of coughing (grade 0: no cough; grade 1: single cough with mild severity; grade 2: cough lasting less than 5 seconds with moderate severity; grade 3: more than 5 seconds of persistent cough)
Measured: Up to one hour after extubation
Secondary outcomes (2)
APGAR score
APGAR stands for "Appearance, Pulse, Grimace, Activity, and Respiration."
In the test, five things are used to check a baby's health. Each is scored on a scale of 0 to 2, with 2 being the best score
Measured: One, 5 and 10 minutes after delivery of the fetus
Sore throat and hoarseness of voice
The incidences and severities of postoperative sore throat and hoarseness of voice will be measured using direct questions
Measured: Postoperative (one, 6 and 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start24 Feb 2021
- Primary completion23 Feb 2022 (estimated)
- Study completion23 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressor ResponseStudies of the same condition, open and under way.
- More trials run by Assiut 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FATMA NABIL AHMED MOHAMED, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441073
- Sponsor's protocol ID
- Lignocaine nebulization stress
- Status last verified
- Jan 2022
- First submitted
- 5 Jun 2020
- Last updated
- 19 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lignocaine Nebulization for Attenuation of Intubation Stress Response in Patients With Severe Pre-eclampsia: a Prospective Double-blinded Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04441073
- Acronym / sponsor ID
- Lignocaine nebulization stress
- Conditions
- Pressor Response
- Keywords
- pressor response, pre-eclampsia, Lignocaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 23 Feb 2022 (estimated)
- Study completion
- 23 Feb 2022 (estimated)
- First posted
- 22 Jun 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 lignocaine nebulization on attenuation of the pressor response during induction and emergence of anesthesia in patients with severe pre-eclampsia
Detailed description
The pressor response to laryngoscopy and tracheal intubation is a very important issue in hypertensive pregnant patients that can lead to increased maternal intracranial pressure, cerebral haemorrhage, and cardiac failure with pulmonary oedema and may result in maternal mortality. The catecholamine release associated with laryngoscopy and intubation also causes uteroplacental vasoconstriction and adversely affect the neonate well-being.
Therefore, the precise control of stress is necessary during general anesthesia in pre-eclamptic patients.Various drugs are used to suppress the pressor response including opioids, lidocaine, along with α and β adrenergic blockers.
in this study the investigators will evaluate the effect of lignocaine nebulization on attenuation of the pressor response.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lignocaine | Experimental | Drug: Lignocainepreoperative nebulization of lignocaine |
| Placebo | Placebo comparator | Drug: Placebopreoperative nebulization of normal saline (Nacl 0.9%) as a placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologist (ASA) II , III with severe pre-eclampsia
- Scheduled for caesarean deliveries under general anesthesia
Key exclusion criteria (6 listed)
- severe obesity (BMI ≥ 40 )
- Cardiac patients
- History of diabetes
- Renal dysfunction (Elevated creatinine ≥ 2 mg\dl)
- Hepatic dysfunction (Elevated hepatic enzymes three times above normal value)
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 |
|---|---|---|
| Lignocainepreoperative nebulization of lignocaine | Drug | Lignocaine |
| PlaceboAlso: Normal saline (Nacl 0.9%)preoperative nebulization of normal saline (Nacl 0.9%) as a placebo | Drug | Placebo |
Primary outcome
Systolic, diastolic, mean arterial blood pressure
Time frame: Preoperative-Intraoperative
Heart rate
Time frame: Preoperative-Intraoperative
Peripheral oxygen saturation
Time frame: Preoperative-Intraoperative
Cough score during emergence
Time frame: Up to one hour after extubation
Grade of coughing (grade 0: no cough; grade 1: single cough with mild severity; grade 2: cough lasting less than 5 seconds with moderate severity; grade 3: more than 5 seconds of persistent cough)
2 secondary outcomes
APGAR score
Time frame: One, 5 and 10 minutes after delivery of the fetus
Sore throat and hoarseness of voice
Time frame: Postoperative (one, 6 and 24 hours)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Pressor Response
Recruiting
Neurophysiological and Autonomic Responses to Acute Physical and Emotional Stress: An EEG Study
Stress, Acute Stress
Recruiting
Cardiovascular Function and Response to Stimulation Within the First Year After Spinal Cord Injury
Spinal Cord Injuries (SCI), Orthostatic Hypotension, Dysautonomic
Not yet recruiting
Dexmedetomidine Nebulization for Attenuation of Pressor Response to Laryngoscopy and Endotracheal Intubation in Sever Preeclamptic Patients
Pressor Response
RecruitingPhase 1/2
Effect of Dexmedetomidine on Hemodynamic Response to Endotracheal Intubation in Hypertensive Patients
Elective Surgical Patient, Hypertensive Patients
Not yet recruitingPhase 1/2
Gabapentin and Pressor Response to Intubation
Elective Surgical Patients, Blood Pressure
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.
Alaa A. Gharib, M.B.B.Ch. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lignocaine in people with Pressor Response, run by Assiut 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 6 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 19 Jan 2022. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Fatma N. Mohamed, M.D. (+201003633992, fatmanabil2012@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic, diastolic, mean arterial blood pressure (time frame: Preoperative-Intraoperative). The study lists 4 primary outcomes in all. 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 19 Jan 2022.