Intracuff Dexmedetomidine Versus Alkalinized Lidocaine for Peri-Extubation Cough and Hemodynamic Responses in Elderly Patients
NCT07916246, Not applicable, Not yet recruiting, Beni-Suef University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Intracuff Dexmedetomidine Versus Alkalinized Lidocaine for Peri-Extubation Cough and Hemodynamic Responses in Elderly Patients | ClinicalTrials.gov |
| NCT number | NCT07916246 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 184 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Beni-Suef University | ClinicalTrials.gov |
| Conditions | Airway Complication of Anesthesia, Hemodynamic Instability, Postoperative Complications, Emergence Delirium, Anesthesia | ClinicalTrials.gov |
| Interventions | Dexmedetomidine, Alkalinized Lidocaine | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Incidence of Smooth Extubation | During the first 60 seconds post-extubation | Proportion (percentage) of participants in each group achieving smooth extubation, defined as a cough score of 0 or 1 on a validated 4-point scale during the first 60 seconds after tube removal. Assessment begins continuously at the exact moment the endotracheal tube cuff passes through the vocal cords (marked by stopwatch). Cough Scale: * 0 = No cough * 1 = Single mild cough * 2 = Moderate coughing (2-3 coughs) * 3 = Severe coughing (≥4 coughs or bucking) A score of 0-1 indicates smooth extubation (desirable outcome). | ClinicalTrials.gov |
| Secondary | Peri-Extubation Cough Severity Score | During the first 60 seconds post-extubation | Distribution and median score of peri-extubation cough severity evaluated on the 4-point ordinal scale (0 = No cough, 1 = Single mild cough, 2 = Moderate coughing \[2-3 coughs\], 3 = Severe coughing \[≥4 coughs or bucking\]). Lower scores indicate better outcomes. | ClinicalTrials.gov |
| Secondary | Maximum Percentage Change in Mean Arterial Pressure (MAP) and Heart Rate (HR) | From 1 minute before extubation up to 10 minutes post-extubation | Maximum absolute and percentage change from baseline in MAP (mmHg) and HR (beats/min). Pre-induction baseline is defined as the mean of three resting readings at 2-minute intervals. Additionally, the proportion of participants experiencing a clinically significant hemodynamic response (defined as MAP or HR increase \>20% above baseline sustained for ≥2 consecutive readings) will be reported. | ClinicalTrials.gov |
| Secondary | Incidence and Severity of Postoperative Sore Throat (POST) | At 1, 6, 12, and 24 hours post-extubation | Incidence and severity of POST assessed on a 4-point scale: 0 = None (no sore throat), 1 = Mild (discomfort with swallowing), 2 = Moderate (constant discomfort, worse with swallowing), 3 = Severe (severe pain interfering with eating/speaking). Lower scores indicate less airway morbidity. | ClinicalTrials.gov |
| Secondary | Incidence and Severity of Postoperative Hoarseness | At 1, 6, 12, and 24 hours post-extubation | Incidence and severity of hoarseness assessed on a 4-point scale: 0 = None (normal voice), 1 = Mild (noticed only by patient), 2 = Moderate (noticeable voice change to observer), 3 = Severe (aphonia or severe hoarseness). Lower scores indicate less vocal cord dysfunction. | ClinicalTrials.gov |
| Secondary | Emergence Times and Time to PACU Recovery | From anesthetic discontinuation up to 120 minutes postoperatively | Time intervals (in minutes) measured from discontinuation of volatile anesthetic (sevoflurane) to: (1) Eye opening, (2) Following verbal commands, (3) Tracheal extubation, and (4) Time to achieve an Aldrete recovery score ≥9 in the PACU. | ClinicalTrials.gov |
| Secondary | Richmond Agitation-Sedation Scale (RASS) Score | At 1, 3, 5, and 10 minutes post-extubation | Emergence agitation or sedation evaluated using the Richmond Agitation-Sedation Scale (RASS), ranging from -5 (unarousable) to +4 (combative), with 0 indicating alert and calm. | ClinicalTrials.gov |
| Secondary | Incidence of Perioperative Adverse Events and Hemodynamic Complications | Through 24 hours postoperatively | Proportion of participants experiencing safety events: bradycardia (HR \<50 bpm or requiring atropine), hypotension (MAP \<65 mmHg or \>30% drop from baseline requiring vasopressors), hypoxemia (SpO2 \<92%), arrhythmias, bronchospasm, laryngospasm, reintubation, unexpected ICU admission, and in-hospital mortality. | ClinicalTrials.gov |
| Secondary | Composite Smooth Extubation Rate [Exploratory Endpoint] | During the first 10 minutes post-extubation | Proportion of participants meeting all three composite criteria simultaneously: (1) Cough score 0-1 during first 60 s post-extubation AND (2) Maximum MAP and HR change ≤20% from baseline AND (3) Absence of severe agitation (RASS ≤+2). Retained for contextual comparison with legacy literature. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)