A comparison of two methods of hypotensive anaestesia during mastoid surgery

Completed

• Conditions: Diseases of middle ear and mastoid,

• Registration Number: CTRI/2018/02/011945
• Lead Sponsor: Jubilee Mission Medical College and Research Institute

Brief Summary

Controlled hypotensive anaesthesia is very useful in mastoid surgery using operating microscope to obtain a good surgical field. This study compares two methods of maintaining controlled heart rate and blood pressure.

Methods: There were 2 groups, D and P of 35 patients each. General anaesthesia was induced by a common protocol. In group D, dexmedetomidine bolus (0.2 mcg/kg) at induction and infusion (0.2 mcg/kg/h) were given. In group P, propofol boluses (1 mg/kg) were used to maintain hypotension. Target mean arterial pressure (MAP) was 55- 65 mm Hg and target heart rate 60 -75 beats per minute. Parameters noted were heart rate and blood pressure (systolic, diastolic, mean), need of other interventions to maintain heart rate ( beta blocker or atropine) and blood pressure (vasopressor, increasing concentration of inhalational agent), intraoperative bleeding score and recovery room parameters (pain, shivering, nausea and vomiting)

Results & Discussion : Both arms maintained MAP within the target range. Dexmedetomidine at dose of 0.2 mcg/kg bolus and infusion, is equally efficacious as Propofol boluses in maintaining mean arterial pressure within a range of 55 – 65 mm Hg. Heart rate control (60-75 per minute) was better in dexmedetomidine group, requiring significantly lesser amount of beta blocker than propofol. Use of  Dexmedetomidine, even in such a lower dose, significantly reduced the requirement of inhalational agent. Dexmedetomidine did not increase incidence of postoperative sedation or postoperative nausea and vomiting.

Conclusions: Dexmedetomidine at a dose of 0.2 mcg/kg bolus and infusion, is equally efficacious as propofol boluses in maintaining mean arterial pressure within a range of 55 – 65 mm Hg. Heart rate control was better in dexmedetomidine group, requiring significantly lesser amount of beta blocker than propofol. Use of  Dexmedetomidine, even at this lower dose, significantly reduced the requirement of inhalational agent without increasing the incidence of sedation or postoperative nausea and vomiting.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10-10
• Study Completion: 2017-07-14
• Last Update Posted: 2019-11-28

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. American Society of Anaesthesiologists ( ASA) Category I – II patients 2)aged 18 – 55 years 3)undergoing middle ear surgery.

Exclusion Criteria

1. Coexisting hepatic, renal, cardiovascular, neuromuscular or hematological diseases 2) Patients on antipsychotics, adrenergic blockers, Monoamine oxidase (MAO) inhibitors 3)History of drug allergy to alpha-2 agonists.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main aim of study is to know the drug’s efficacy in maintaining hypotension and	October 2016 TO September 2017
lowering heart rate which affects the quality of the surgical field.	October 2016 TO September 2017

Secondary Outcome Measures

Name	Time	Method
Quality of surgical field, incidence of bradycardia and postoperative pain, nausea and vomiting,sedation and shivering	October 2016 TO September 2017

Trial Locations

Locations (1)

Jubilee Mission Medical College & Research Institute; 🇮🇳 Thrissur, KERALA, India

Jubilee Mission Medical College & Research Institute

🇮🇳Thrissur, KERALA, India

Dr Anuradha T

Principal investigator

9847120761

anuradha_t2000@yahoo.com