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Comparison of drugs for anxiety relief before heart surgery

Randomized blind prospective study: a comparison of midazolan, morphine or clonidine as premedication for cardiac surgery - COMPRECC: COMparison of midazolan, morphine or clonidine as PREmedication for Cardiac surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
REBEC
Registry ID
RBR-83ckh3
Enrollment
Unknown
Registered
2012-02-13
Start date
2011-08-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with cardiac disease who will undergo cardiac surgery

Interventions

The patients wil be divided into 3 groups(n=30 in each). The groups will receive the medication 45 minutes prior to surgery. Midazolam group:midazolam 7,5 mg, orally. Morphine group: morphine 0,2 mg/k
Drug

Sponsors

Instituto de Cardiologia do Rio Grande do Sul
Lead Sponsor
Ari Tadeu Lírio dos Santos
Collaborator

Eligibility

Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients undergoing cardiac surgery with cardiopulmonary bypass; age of 18-65 years.

Exclusion criteria

Exclusion criteria: Non-elective surgery; weigh less than 50 or more than 100 kg; history of psychiatric disorder; ASA physics status of class IV; patients with a mental impairment, knowledge about allergy to studied drugs; patients with congenital cardiac disease and the patients that don't give informed consent.

Design outcomes

Primary

MeasureTime frame
The effect of midazolam, clonidine and morphine on the systolic arterial pressure in patients undergoing cardiac surgery, on arrival to operating room. On arrival to operating room will be measured the blood pressure (systolic) of patient.

Secondary

MeasureTime frame
Effects of three drugs on level of sedation. Sedation will be evaluated by Ramsay Scale.;Effects of three drugs on level of anxiety. Anxiety will be measured by visual analog scale (VAS), on arrival to operating room.;Effects of three drugs on cardiac rate. Will be measured the cardiac rate on arrival to operating room.;Effects of three drugs on respiratory rate. The respiratory rate will be measured on arrival to operating room.;Effects of three drugs on oxygen saturation level. The arterial oxygen saturation level will be measured by pulse oximeter. ;Effects of three drugs on perception of pain caused by arterial and venous puncture. The pain perception will be evaluated by VAS.;Effects of three drugs on recall (amnésia). The amnésia will be evaluated by showing to patients 3 pictures and 3 words, printed on a card. At postoperative period, after awakening, the patients will be queried to recall of the pictures and words.

Countries

Brazil

Contacts

Public ContactMaria Guedes

Comitê de Ética em Pesquisa

secretariageral-up@cardiologia.org.br+51(51)3230-3600 - Ramal 3898

Outcome results

None listed

Source: REBEC (via WHO ICTRP)