Rapid Sequence Induction: Succinyl Choline vs Rocuronium After Pretreatment With Dexmedetomidine

NCT04709315 | Unknown Phase 3

• 1 other identifier: southvu7
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Rapid sequence induction is a well-established anesthetic procedure used in trauma setting and patients with full stomach. Succinyl choline has the been the drug of choice, however, it carries potential risk and sometimes fatal outcome. Aim of the study: to compare rocuronium after pre-treatment with Dexmedetomidine, to succinyl choline in providing excellent intubating conditions. Material and method: Patients were randomly allocated to one of two groups, of 120 each. Control (SS) group, patients received pretreatment with 10 ml 0.9% saline over 10 minutes, and succinyl choline 1mg/ kg was on induction. Experimental (DR) group, received pretreatment with Dex 1 µg / kg in 10 ml 0.9% saline over 10 minutes and rocuronium 0.6 mg/kg on induction.

Conditions

Rapid Sequence Induction

Outcome Measures

Primary Outcomes (1)

• number of patients with excellent intubating conditions

  This score is based on triad of signs: how easy to insert the laryngoscope, the anatomical position of the vocal cords, and how patients react to the introduction of the laryngoscope

  60 seconds after muscle relaxant has been given

Secondary Outcomes (2)

• heart rate

  at induction of anesthesia, 4 and 5 minutes after intubation.

• mean blood pressure

  at induction, 4 and 5 minutes after intubation

Study Arms (2)

saline pretreatment/succinyl group (SS group).

ACTIVE COMPARATOR

patients receive pretreatment with 10 ml 0.9% saline over 10 minutes, and succinyl choline 1mg/ kg is the intubating muscle relaxant.

Drug: 0.9% saline and succinyl choline 1mg/ kg

Dex pretreatment/ rocuronium group (DR group),

EXPERIMENTAL

patients receive pretreatment with Dex 1 µg / kg in 10 ml 0.9% saline over 10 minutes and rocuronium 0.6 mg/kg is the intubating muscle relaxant.

Drug: dexemedetomidine and rocuronium

Interventions

dexemedetomidine and rocuronium DRUG

In the DR group, patients received pretreatment with Dex 1 µg / kg in 10 ml 0.9% saline over 10 minutes and rocuronium 0.6 mg/kg was the intubating muscle relaxant

Dex pretreatment/ rocuronium group (DR group),

0.9% saline and succinyl choline 1mg/ kg DRUG

0.9% saline over 10 minutes, and succinyl choline 1mg/ kg

saline pretreatment/succinyl group (SS group).

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I or II
• scheduled for elective surgery of more than 60 minutes duration. -

You may not qualify if:

• Mallampati score of III or IV
• Neuromuscular disease
• History of allergy to the studied drugs
• Malignant hyperthermia
• Patients taking anticonvulsants or aminoglycoside antibiotic
• Hepatic dysfunction
• Renal dysfunction
• Cardiovascular dysfunction;
• Electrolyte imbalance
• Morbidly obese with a body mass index (BMI) more than 30 kg/m2
• Pregnant or nursing mothers.

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

South Valley University Hospitals

Qina, Qena Governorate, 85203, Egypt

Location

MeSH Terms

Interventions

Rocuronium; Sodium Chloride

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• ossama salman, MD

  South Valley University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: that the anesthetist who prepared the experimented drugs was different from the one who was responsible for administration of all medications during induction and maintenance and was responsible for the patient throughout the surgery till patient was ready to transfer to PACU. An independent third anesthetist blinded to the experimental drug administration, carried out intubation and scored intubating conditions. This independent anesthetist, was summoned to enter the operating room 45 seconds after neuromuscular relaxant was administered, when the patient was ready for intubation. Moreover,All drugs administered in control group (saline 0.9%- succinyl; 1mg/kg) and experimental group (Dex; 1 µg/kg- rocuronium; 0.6mg/kg), were prepared in 10 mL syringe and were given via infusion pump. Saline and Dex were given over 10 minutes immediately prior to induction.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 14, 2021
• Study Start: October 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: January 14, 2021

Record last verified: 2021-01

Locations

EG (1)