IntubationLAB-LIG RCTNCT07192081
Comparative Efficacy of Intravenous Labetalol and Lignocaine in Mitigating Hemodynamic Responses to Laryngoscopy During Laparoscopic Cholecystectomy
A study testing Labetalol and Lignocaine in people with Intubation and Anesthesia, run by Dr. Waseem Ullah at 1 site in Pakistan.
Trial summary
Laryngoscopy and intubation during laparoscopic cholecystectomy often cause sudden increases in heart rate and blood pressure, which can be harmful in some patients. Medications such as labetalol and lignocaine are commonly used to reduce this hemodynamic response. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Intubation, Anesthesia, Laparoscopic Cholecystectomy
- What is being tested?
- Labetalol and Lignocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Jun 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA Grade I and II
- Age 18 to 60 years
- Elective laparoscopic cholecystectomy
- Both genders
- Informed consent given
Who cannot join
- Hypersensitivity to labetalol/lignocaine
- Hypertensive on antihypertensives
- ASA Grade III or more
- Cardiovascular, renal, hepatic, or endocrine issues
- Pregnant/lactating
- BMI ≥ 35
- Anticipated difficult airway
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Hayatabad Med Complex
Peshawar, Khyber Pakhtunkhwa, 25000
Shahkar Khan Trainee Medical Officer, Mbbs, 92 310 1185828, muhammadkmcite@gmail.com
About this study
Official title: Comparative Efficacy of Intravenous Labetalol and Lignocaine in Mitigating Hemodynamic Responses to Laryngoscopy During Laparoscopic Cholecystectomy: A Randomized Controlled Trial
Laryngoscopy and intubation during laparoscopic cholecystectomy often cause sudden increases in heart rate and blood pressure, which can be harmful in some patients. Medications such as labetalol and lignocaine are commonly used to reduce this hemodynamic response. This randomized controlled trial at Hayatabad Medical Complex, Peshawar, will compare intravenous labetalol (0.25 mg/kg) and lignocaine (1.5 mg/kg), administered 3 minutes before laryngoscopy. A total of 116 patients undergoing elective laparoscopic cholecystectomy will be randomly assigned to either drug group. The primary goal is to determine which drug is more effective in keeping heart rate and mean arterial pressure within ±20% of baseline during and after intubation. The study will also record blood pressure trends, intubation details, rescue medications, and adverse events such as bradycardia or hypotension. Results will help guide anesthesiologists in selecting the safer and more effective option to maintain cardiovascular stability during surgery.
Read the detailed description
Laparoscopic cholecystectomy is the standard surgical treatment for symptomatic gallstones. However, laryngoscopy and endotracheal intubation during anesthesia often trigger a sympathetic surge, resulting in tachycardia and hypertension. These hemodynamic changes, although short-lived, may increase perioperative risk, especially in patients with limited cardiovascular reserve.
Labetalol, a combined α1- and β-adrenergic antagonist, reduces both heart rate and arterial pressure by blunting sympathetic activity. Lignocaine, an amide local anesthetic, also exhibits sympatholytic effects when given intravenously. Both agents are widely used in anesthesia practice, but direct head-to-head evidence in the setting of laparoscopic cholecystectomy remains limited.
This randomized controlled study will evaluate and compare the efficacy of intravenous labetalol and lignocaine in attenuating pressor and tachycardic responses to laryngoscopy. The trial will include adult ASA I patients scheduled for elective laparoscopic cholecystectomy. Participants will be randomly assigned to receive either labetalol 0.25 mg/kg or lignocaine 1.5 mg/kg intravenously, 3 minutes before laryngoscopy. Hemodynamic variables (heart rate, systolic, diastolic, and mean arterial pressures) will be tracked peri-intubation. The occurrence of adverse events such as bradycardia, hypotension, or allergic reactions will also be monitored.
By directly comparing these two commonly used drugs in a controlled setting, the study aims to clarify which provides superior cardiovascular stability during airway instrumentation. Findings will contribute to evidence-based guidance for anesthesiologists in selecting pharmacologic strategies that minimize perioperative risk in laparoscopic surgery.
- Conditions
- Intubation, Anesthesia, Laparoscopic Cholecystectomy, Hemodynamic Response to Laryngoscopy
- Being tested
- Labetalol, Lignocaine
- Keywords
- Attenuation of Sympathetic Response, Perioperative Management, Randomized Controlled Trial, Endotracheal Intubation, Hemodynamic Stability, Lignocaine, Labetalol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LabetalolDrug
Labetalol 0.25 mg/kg intravenous bolus over 60 seconds, administered 3 minutes before laryngoscopy.
LignocaineDrug
Lignocaine 1.5 mg/kg intravenous bolus over 60 seconds, administered 3 minutes before laryngoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Labetalol Group | Experimental | Patients in this arm will receive intravenous labetalol at a dose of 0.25 mg/kg over 60 seconds, 3 minutes prior to laryngoscopy and intubation. Receives: Drug: Labetalol |
| Lignocaine Group | Active comparator | Patients in this arm will receive intravenous lignocaine at a dose of 1.5 mg/kg over 60 seconds, 3 minutes prior to laryngoscopy and intubation. Receives: Drug: Lignocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Systolic Blood Pressure (SBP) Following Laryngoscopy
To evaluate and compare the effect of intravenous labetalol and lignocaine on systolic blood pressure changes in response to laryngoscopy during induction for laparoscopic cholecystectomy.
Measured: From 5 minutes before induction to 10 minutes after intubation.
Secondary outcomes (4)
Change in Diastolic Blood Pressure (DBP)
To assess diastolic blood pressure response post-laryngoscopy between both groups.
Measured: From 5 minutes before induction to 10 minutes after intubation.
Change in Mean Arterial Pressure (MAP)
To compare MAP variations post-induction and post-laryngoscopy.
Measured: From 5 minutes before induction to 10 minutes after intubation..
Change in Heart Rate
To evaluate the impact of interventions on HR response to laryngoscopy.
Measured: From 5 minutes before induction to 10 minutes after intubation.
Incidence of Adverse Events
Number of participants experiencing side effects such as bradycardia, hypotension, or allergic reaction.
Measured: From induction through recovery (approx. 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start5 Jun 2025
- Primary completion4 Jan 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntubationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, randomized, single-blind, parallel-arm trial comparing IV labetalol and lignocaine in adult patients undergoing laparoscopic cholecystectomy.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Waseem Ullah
- Sponsor type
- Other government
- Collaborators
- Hayatabad Medical Complex
- Responsible party
- Sponsor-investigator, Dr. Waseem Ullah, Lady Reading Hospital, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192081
- Sponsor's protocol ID
- CPSP/REU/ANS-2023-021-3099
- Acronym
- LAB-LIG RCT
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) will not be shared due to institutional policies, privacy concerns, and limitations in data-sharing infrastructure.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Intravenous Labetalol and Lignocaine in Mitigating Hemodynamic Responses to Laryngoscopy During Laparoscopic Cholecystectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07192081
- Acronym / sponsor ID
- LAB-LIG RCT / CPSP/REU/ANS-2023-021-3099
- Conditions
- Intubation, Anesthesia, Laparoscopic Cholecystectomy, Hemodynamic Response to Laryngoscopy
- Keywords
- Attenuation of Sympathetic Response, Perioperative Management, Randomized Controlled Trial, Endotracheal Intubation, Hemodynamic Stability, Lignocaine, Labetalol
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Dr. Waseem UllahOther government
- Collaborators
- Hayatabad Medical Complex
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- 4 Jan 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 25 Sep 2025 (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.
Laryngoscopy and intubation during laparoscopic cholecystectomy often cause sudden increases in heart rate and blood pressure, which can be harmful in some patients. Medications such as labetalol and lignocaine are commonly used to reduce this hemodynamic response. This randomized controlled trial at Hayatabad Medical Complex, Peshawar, will compare intravenous labetalol (0.25 mg/kg) and lignocaine (1.5 mg/kg), administered 3 minutes before laryngoscopy. A total of 116 patients undergoing elective laparoscopic cholecystectomy will be randomly assigned to either drug group. The primary goal is to determine which drug is more effective in keeping heart rate and mean arterial pressure within ±20% of baseline during and after intubation. The study will also record blood pressure trends, intubation details, rescue medications, and adverse events such as bradycardia or hypotension. Results will help guide anesthesiologists in selecting the safer and more effective option to maintain cardiovascular stability during surgery.
Detailed description
Laparoscopic cholecystectomy is the standard surgical treatment for symptomatic gallstones. However, laryngoscopy and endotracheal intubation during anesthesia often trigger a sympathetic surge, resulting in tachycardia and hypertension. These hemodynamic changes, although short-lived, may increase perioperative risk, especially in patients with limited cardiovascular reserve.
Labetalol, a combined α1- and β-adrenergic antagonist, reduces both heart rate and arterial pressure by blunting sympathetic activity. Lignocaine, an amide local anesthetic, also exhibits sympatholytic effects when given intravenously. Both agents are widely used in anesthesia practice, but direct head-to-head evidence in the setting of laparoscopic cholecystectomy remains limited.
This randomized controlled study will evaluate and compare the efficacy of intravenous labetalol and lignocaine in attenuating pressor and tachycardic responses to laryngoscopy. The trial will include adult ASA I patients scheduled for elective laparoscopic cholecystectomy. Participants will be randomly assigned to receive either labetalol 0.25 mg/kg or lignocaine 1.5 mg/kg intravenously, 3 minutes before laryngoscopy. Hemodynamic variables (heart rate, systolic, diastolic, and mean arterial pressures) will be tracked peri-intubation. The occurrence of adverse events such as bradycardia, hypotension, or allergic reactions will also be monitored.
By directly comparing these two commonly used drugs in a controlled setting, the study aims to clarify which provides superior cardiovascular stability during airway instrumentation. Findings will contribute to evidence-based guidance for anesthesiologists in selecting pharmacologic strategies that minimize perioperative risk in laparoscopic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-center, randomized, single-blind, parallel-arm trial comparing IV labetalol and lignocaine in adult patients undergoing laparoscopic cholecystectomy.
| Arm | Type | Receives |
|---|---|---|
| Labetalol Group | Experimental | Drug: LabetalolPatients in this arm will receive intravenous labetalol at a dose of 0.25 mg/kg over 60 seconds, 3 minutes prior to laryngoscopy and intubation. |
| Lignocaine Group | Active comparator | Drug: LignocainePatients in this arm will receive intravenous lignocaine at a dose of 1.5 mg/kg over 60 seconds, 3 minutes prior to laryngoscopy and intubation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- ASA Grade I and II
- Age 18 to 60 years
- Elective laparoscopic cholecystectomy
- Both genders
- Informed consent given
Key exclusion criteria (7 listed)
- Hypersensitivity to labetalol/lignocaine
- Hypertensive on antihypertensives
- ASA Grade III or more
- Cardiovascular, renal, hepatic, or endocrine issues
- Pregnant/lactating
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 |
|---|---|---|
| LabetalolLabetalol 0.25 mg/kg intravenous bolus over 60 seconds, administered 3 minutes before laryngoscopy. | Drug | Labetalol Group |
| LignocaineLignocaine 1.5 mg/kg intravenous bolus over 60 seconds, administered 3 minutes before laryngoscopy. | Drug | Lignocaine Group |
Primary outcome
Change in Systolic Blood Pressure (SBP) Following Laryngoscopy
Time frame: From 5 minutes before induction to 10 minutes after intubation.
To evaluate and compare the effect of intravenous labetalol and lignocaine on systolic blood pressure changes in response to laryngoscopy during induction for laparoscopic cholecystectomy.
4 secondary outcomes
Change in Diastolic Blood Pressure (DBP)
Time frame: From 5 minutes before induction to 10 minutes after intubation.
Change in Mean Arterial Pressure (MAP)
Time frame: From 5 minutes before induction to 10 minutes after intubation..
Change in Heart Rate
Time frame: From 5 minutes before induction to 10 minutes after intubation.
Incidence of Adverse Events
Time frame: From induction through recovery (approx. 1 hour)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: No. The individual participant data (IPD) will not be shared due to institutional policies, privacy concerns, and limitations in data-sharing infrastructure.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Labetalol and Lignocaine in people with Intubation and Anesthesia, run by Dr. Waseem Ullah at 1 site in Pakistan.
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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 25 Sep 2025. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Systolic Blood Pressure (SBP) Following Laryngoscopy (time frame: From 5 minutes before induction to 10 minutes after intubation.). 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 25 Sep 2025.