Block Pressor Response to Intubation

NCT05659212 | Unknown

• 1 other identifier: SM 11 2022
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

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

Conditions

Intubation Complication

Outcome Measures

Primary Outcomes (1)

• Heart rate (HR)

  Beats/ minute

  10 minutes before intubation to one hour after surgery

Study Arms (3)

Group D

ACTIVE COMPARATOR

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

Group M

ACTIVE COMPARATOR

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

Group L

PLACEBO COMPARATOR

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

Interventions

Dexmedetomidine DRUG

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.

Group D

Magnesium sulphate DRUG

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.

Group M

Lidocaine DRUG

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.

Group L

Eligibility Criteria

• Age: 23 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Dexmedetomidine; Magnesium Sulfate; Lidocaine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Seham M. Moeen, MD

CONTACT

01006386324; seham.moeen@aun.edu.eg

ARMIA M. LABEB, Msc

CONTACT

01091507030

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Anesthesia and Intensive Care

Study Record Dates

• First Submitted: November 25, 2022
• First Posted: December 21, 2022
• Study Start: January 3, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: December 21, 2022

Record last verified: 2022-12