CClinicalTrials.gg
Status unknownNCT05659212Updated Dec 21, 2022

Block Pressor Response to Intubation

An interventional study of Dexmedetomidine and Magnesium sulphate in Intubation Complication, sponsored by Assiut University. Status unknown. Open to female participants aged 23 Years to 40 Years. Per ClinicalTrials.gov, last updated 2022-12-21.

Sponsored by Assiut University · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Dec 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
23 Years to 40 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Intubation Complication
03

In context

Lead sponsor

Assiut University is the lead sponsor of 4,916 studies on the registry; 2,113 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
23 Years to 40 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
102 participants (estimated)

Study arms

  • 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

  • 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

  • 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

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.

06

What researchers measure

Primary outcomes

  1. Heart rate (HR)

    Beats/ minute

    Time frame: 10 minutes before intubation to one hour after surgery

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05659212
Lead sponsor
Assiut University
Responsible party
Seham Mohamed Moeen Ibrahim (Assistant professor of Anesthesia and Intensive Care, Assiut University) — Principal investigator
First posted
Dec 21, 2022
Start date
Jan 3, 2023 (estimated)
Primary completion
Jan 31, 2024 (estimated)
Completion
Jan 31, 2024 (estimated)
Last update
Dec 21, 2022

Study contacts

Seham M. Moeen, MD
Contact
seham.moeen@aun.edu.eg
01006386324 ext. 02
ARMIA M. LABEB, Msc
Contact
01091507030 ext. 02

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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