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Block Pressor Response to Intubation

A Comparative Randomized Study Between Dexmedetomidine, Magnesium Sulphate and Lidocaine on the Pressor Response to Laryngoscopic Intubation for Laparoscopic Gynecological Surgery

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05659212
Enrollment
102
Registered
2022-12-21
Start date
2023-01-03
Completion date
2024-01-31
Last updated
2022-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation Complication

Brief summary

Laryngoscopy and endotracheal intubation are necessary for effective control of airway and ventilation, but it has deleterious effects such as hypertension and disrhythmia

Detailed description

Fast-track laparoscopic gynecological surgery usually done under general anesthesia (GA). Laryngoscopy and endotracheal intubation are necessary for effective control of airway and ventilation, but it has deleterious effects such as hypertension and disrhythmia. These hemodynamic changes are due to the reflex sympathetic activity and the magnitude of response is directly proportional to the duration and strength of laryngoscopy. Several drugs and techniques have been tried to attenuate the stress response to laryngoscopy and endotracheal intubation, but none of them have proven to be ideal. Lidocaine is an amide synthetic local anesthetic, which is used in treatment of ventricular dysrhythmias and as a prophylaxis in ventricular tachyarrhythmia. It has cardio stabilizing action. Bromage showed that its intravenous (IV) use blunted pressure response to intubation. An IV dose of lidocaine 1.5 mg/kg has been proved to attenuate stress responses during laryngoscopy and intubation. Dexmedetomidine is a highly selective alpha 2 receptor agonist and possesses the properties of sedation, analgesia, and opioid sparing effect. It has been shown to reduce the laryngeal stress response, reduce the requirement of intravenous (IV) anesthetics, and provides hemodynamic stability. Magnesium sulphate (Mg SO4) is the fourth most abundant cation in the body and the second most abundant intracellular cation. It activates many of the enzyme system. Mg SO4 inhibits the release of catecholamines from the adrenal medulla and adrenergic nerve endings and is effective in attenuating the blood pressure (BP) response to tracheal intubation. Puri et al showed that MgSO4 50 mg/kg administered before laryngoscopy could attenuate the pressor response to tracheal intubation better than lidocaine.

Interventions

DRUGDexmedetomidine

Patients will receive IV dexmedetomidine 0.5 μg /kg diluted up to 10 ml with normal saline infused over 10 min before induction of anesthesia, and 10 ml of normal saline immediately before induction of anesthesia.

DRUGMagnesium sulphate

Patients will receive IV magnesium sulphate 50 mg/kg diluted up to 10 ml with normal saline infused slowly over 10 min before induction of anesthesia, and 10 ml of normal saline immediately before induction of anesthesia.

DRUGLidocaine

Patients will receive IV lidocaine 1.5 mg/ kg diluted up to 10 ml with normal saline immediately before induction of anesthesia and 10 ml of normal saline infused over 10 min before induction of anesthesia.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
23 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* ASA physical status I-II * Age between 23 to 40 years * With airway of Mallampati grade I and II * Elective diagnostic laparoscopic gynecologic surgery under general anesthesia with endotracheal intubation

Exclusion criteria

* Mallampatti grading III and IV, anticipated difficult intubation * Body mass index (BMI \> 35 kg/m2), full stomach, pregnancy * Emergency surgery * History of cardiac or neurological disease or patient with asthma * History of Hypersensitivity to the study drugs * Advanced hepatic or renal failure. * Patients in whom the duration of laryngoscopy lasted more than 20 seconds * Patient refusal.

Design outcomes

Primary

MeasureTime frameDescription
Heart rate (HR)10 minutes before intubation to one hour after surgeryBeats/ minute

Contacts

Primary ContactSeham M. Moeen, MD
seham.moeen@aun.edu.eg01006386324
Backup ContactARMIA M. LABEB, Msc
01091507030

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026