Block Pressor Response to Intubation

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05659212
Collaborator
(none)
102
3
12.9

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
102 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Comparative Randomized Study Between Dexmedetomidine, Magnesium Sulphate and Lidocaine on the Pressor Response to Laryngoscopic Intubation for Laparoscopic Gynecological Surgery
Anticipated Study Start Date :
Jan 3, 2023
Anticipated Primary Completion Date :
Jan 31, 2024
Anticipated Study Completion Date :
Jan 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group D

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.

Drug: Dexmedetomidine
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.

Active Comparator: Group M

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.

Drug: Magnesium 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.

Placebo Comparator: Group L

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.

Drug: Lidocaine
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.

Outcome Measures

Primary Outcome Measures

  1. Heart rate (HR) [10 minutes before intubation to one hour after surgery]

    Beats/ minute

Eligibility Criteria

Criteria

Ages Eligible for Study:
23 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Seham Mohamed Moeen Ibrahim, Assistant professor of Anesthesia and Intensive Care, Assiut University
ClinicalTrials.gov Identifier:
NCT05659212
Other Study ID Numbers:
  • SM 11 2022
First Posted:
Dec 21, 2022
Last Update Posted:
Dec 21, 2022
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 21, 2022